—#207659

Product

Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation of cardiac and vascular diseases.

FDA product code: MWI — Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K181311
Affected lot / code info: Software Versions 1.2.0, 1.2.1, 1.2.2, 1.2.3, 1.3.0, 1.3.1. Model No. 722467; UDI: (01)00884838100084 (11)200826(10)5.2.0.0, (01)00884838101180(21)616, (01)00884838101180(21)349, (01)00884838101180(21)2111600488, (01)00884838101180(21)2111601116, (01)00884838101180(21)482, (01)00884838101180(21)412, (01)00884838101180(21)2111601659, (01)00884838101180(21)2111601041, (01)00884838101180(21)2111601582, (01)00884838101180(21)251, (01)00884838101180(21)934, (01)00884838101180(21)305, (01)00884838101180(21)295, (01)00884838101180(21)2111600498, (01)00884838101180(21)217, (01)00884838101180(21)527, (01)00884838101180(21)2111600927, (01)00884838101180(21)247, (01)00884838101180(21)431, (01)00884838101180(21)2111601322, (01)00884838101180(21)2111600711, (01)00884838101180(21)455, (01)00884838101180(21)256, (01)00884838101180(21)268, (01)00884838101180(21)744, (01)00884838101180(21)795, (01)00884838101180(21)800, (01)00884838101180(21)64, (01)00884838101180(21)2111601489, (01)00884838101180(21)685, (01)00884838101180(21)2111600884, 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(01)00884838101180(21)1126, (01)00884838101180(21)357, (01)00884838101180(21)48, (01)00884838101180(21)2111600567, (01)00884838101180(21)2111601040, (01)00884838101180(21)953, (01)00884838101180(21)87, (01)00884838101180(21)259, (01)00884838101180(21)2111600694, (01)00884838101180(21)2111600791, (01)00884838101180(21)2111600924, (01)00884838101180(21)681, (01)00884838101180(21)694, (01)00884838101180(21)24, (01)00884838101180(21)25, (01)00884838101180(21)1088, (01)00884838101180(21)1173, (01)00884838101180(21)2111601091, (01)00884838101180(21)2111600656, (01)00884838101180(21)2111600568, (01)00884838101180(21)2111600578, (01)00884838101180(21)2111600817, (01)00884838101180(21)2111600778, (01)00884838101180(21)324, (01)00884838101180(21)535, (01)00884838101180(21)2111600769, (01)00884838101180(21)2111601672, (01)00884838101180(21)1135, (01)00884838101180(21)2111600433, (01)00884838101180(21)646, (01)00884838101180(21)1140, (01)00884838101180(21)2111601431, (01)00884838101180(21)2111601436, (01)00884838101180(21)2111601437, (01)00884838101180(21)2111601438, (01)00884838101180(21)2111601439, (01)00884838101180(21)889, (01)00884838101180(21)101, (01)00884838101180(21)608, (01)00884838101180(21)609, (01)00884838101180(21)892, (01)00884838101180(21)565, (01)00884838101180(21)821, (01)00884838101180(21)759, (01)00884838101180(21)335, (01)00884838101180(21)1167, (01)00884838101180(21)2111600468, (01)00884838101180(21)7, (01)00884838101180(21)1032, (01)00884838101180(21)1033, (01)00884838101180(21)1160, (01)00884838101180(21)2111601675, (01)00884838101180(21)2111601701, (01)00884838101180(21)2111601702, (01)00884838101180(21)590, (01)00884838101180(21)986, (01)00884838101180(21)987, (01)00884838101180(21)988, (01)00884838101180(21)989, (01)00884838101180(21)990, (01)00884838101180(21)1040, (01)00884838101180(21)2111601143, (01)00884838101180(21)2111601273, (01)00884838101180(21)395, (01)00884838101180(21)2111600551, (01)00884838101180(21)2111600611, (01)00884838101180(21)2111601493, (01)00884838101180(21)2111601494, (01)00884838101180(21)2111601495, (01)00884838101180(21)2111600613, (01)00884838101180(21)2111601221, (01)00884838101180(21)643, (01)00884838101180(21)2111601370, (01)00884838101180(21)729, (01)00884838101180(21)730, (01)00884838101180(21)731, (01)00884838101180(21)2111600635, (01)00884838101180(21)1137, (01)00884838101180(21)1015, (01)00884838101180(21)123, (01)00884838101180(21)124, (01)00884838101180(21)125, (01)00884838101180(21)2111600955, (01)00884838101180(21)2111600956, (01)00884838101180(21)433, (01)00884838101180(21)1106, (01)00884838101180(21)204, (01)00884838101180(21)834, (01)00884838101180(21)2111600684, (01)00884838101180(21)873, (01)00884838101180(21)998, (01)00884838101180(21)2111601213, (01)00884838101180(21)2111601255, (01)00884838101180(21)2111601332, (01)00884838101180(21)2111601323, (01)00884838101180(21)2111601204, (01)00884838101180(21)203, (01)00884838101180(21)2111601706, (01)00884838101180(21)2111601707, (01)00884838101180(21)2, (01)00884838101180(21)3, (01)00884838101180(21)2111601327, (01)00884838101180(21)2111601681, (01)00884838101180(21)262, (01)00884838101180(21)57, (01)00884838101180(21)2111601175, (01)00884838101180(21)150, (01)00884838101180(21)151, (01)00884838101180(21)152, (01)00884838101180(21)138, (01)00884838101180(21)139, (01)00884838101180(21)145, (01)00884838101180(21)156, (01)00884838101180(21)300, (01)00884838101180(21)980, (01)00884838101180(21)2111600495, (01)00884838101180(21)2111601220, (01)00884838101180(21)2111601154, (01)00884838101180(21)2111601798, (01)00884838101180(21)613, (01)00884838101180(21)614, (01)00884838101180(21)2111600763, (01)00884838101180(21)2111601165, (01)00884838101180(21)2111601235, (01)00884838101180(21)283, (01)00884838101180(21)539, (01)00884838101180(21)2111601002, (01)00884838101180(21)182, (01)00884838101180(21)337, (01)00884838101180(21)343, (01)00884838101180(21)344, (01)00884838101180(21)345, (01)00884838101180(21)620, (01)00884838101180(21)2111600445, (01)00884838101180(21)1161, (01)00884838101180(21)86, (01)00884838101180(21)282, (01)00884838101180(21)2111600777, (01)00884838101180(21)2111601725, (01)00884838101180(21)2111601726, (01)00884838101180(21)2111601727, (01)00884838101180(21)2111601728, (01)00884838101180(21)2111600583, (01)00884838101180(21)2111600588, (01)00884838101180(21)2111600589, (01)00884838101180(21)2111600590, (01)00884838101180(21)2111600564, (01)00884838101180(21)655, (01)00884838101180(21)656, (01)00884838101180(21)2111600970, (01)00884838101180(21)132, (01)00884838101180(21)2111601321, (01)00884838101180(21)814, (01)00884838101180(21)575, (01)00884838101180(21)611, (01)00884838101180(21)169, (01)00884838101180(21)191, (01)00884838101180(21)212, (01)00884838101180(21)2111601103, (01)00884838101180(21)2111601104, (01)00884838101180(21)146, (01)00884838101180(21)2111601584, (01)00884838101180(21)948, (01)00884838101180(21)2111601253, (01)00884838101180(21)1147, (01)00884838101180(21)490, (01)00884838101180(21)2111600614, (01)00884838101180(21)2111601550, (01)00884838101180(21)207, (01)00884838101180(21)1141, (01)00884838101180(21)157, (01)00884838101180(21)598, (01)00884838101180(21)2111601248, (01)00884838101180(21)2111600451, (01)00884838101180(21)192, (01)00884838101180(21)188, (01)00884838101180(21)189, (01)00884838101180(21)190, (01)00884838101180(21)2111600692, (01)00884838101180(21)2111600963, (01)00884838101180(21)2111600964, (01)00884838101180(21)2111600965, (01)00884838101180(21)2111600966, (01)00884838101180(21)763, (01)00884838101180(21)776, (01)00884838101180(21)263, (01)00884838101180(21)1020, (01)00884838101180(21)1021, (01)00884838101180(21)1022, (01)00884838101180(21)841, (01)00884838101180(21)2111600651, (01)00884838101180(21)310, (01)00884838101180(21)311, (01)00884838101180(21)2111600824, (01)00884838101180(21)2111600825, (01)00884838101180(21)278, (01)00884838101180(21)373, (01)00884838101180(21)2111600693, (01)00884838101180(21)93, (01)00884838101180(21)612, (01)00884838101180(21)11, (01)00884838101180(21)186, (01)00884838101180(21)793, (01)00884838101180(21)706, (01)00884838101180(21)2111600659, (01)00884838101180(21)2111600660, (01)00884838101180(21)653, (01)00884838101180(21)961, (01)00884838101180(21)2111601446, (01)00884838101180(21)898, (01)00884838101180(21)665, (01)00884838101180(21)2111600627, (01)00884838101180(21)2111600463, (01)00884838101180(21)662, (01)00884838101180(21)1086, (01)00884838101180(21)1162, (01)00884838101180(21)2111600541, (01)00884838101180(21)2111600479, (01)00884838101180(21)2111600480, (01)00884838101180(21)2111601720, (01)00884838101180(21)530, (01)00884838101180(21)607, (01)00884838101180(21)339, (01)00884838101180(21)2111601054, (01)00884838101180(21)119, (01)00884838101180(21)120, (01)00884838101180(21)2111600658, (01)00884838101180(21)756, (01)00884838101180(21)2111600992, (01)00884838101180(21)720, (01)00884838101180(21)633, (01)00884838101180(21)725, (01)00884838101180(21)377, (01)00884838101180(21)384, (01)00884838101180(21)2111600602, (01)00884838101180(21)2111600668, (01)00884838101180(21)2111601652, (01)00884838101180(21)2111600560, (01)00884838101180(21)2111600846, (01)00884838101180(21)599, (01)00884838101180(21)491, (01)00884838101180(21)288, (01)00884838101180(21)950, (01)00884838101180(21)606, (01)00884838101180(21)143, (01)00884838101180(21)667, (01)00884838101180(21)135, (01)00884838101180(21)1039, (01)00884838101180(21)82, (01)00884838101180(21)2111600525, (01)00884838101180(21)2111600530, (01)00884838101180(21)2111601250, (01)00884838101180(21)159, (01)00884838101180(21)2111600499, (01)00884838101180(21)468, (01)00884838101180(21)2111601547, (01)00884838101180(21)658, (01)00884838101180(21)2111601319, (01)00884838101180(21)1037 (01)00884838101180(21)600, (01)00884838101180(21)1197, (01)00884838101180(21)83, (01)00884838101180(21)78, (01)00884838101180(21)2111600545, (01)00884838101180(21)2111600554, (01)00884838101180(21)2111601249, (01)00884838101180(21)1007, (01)00884838101180(21)2111601688; Serial No: CZC9509HWC, CZC950919K, CZC9509HTZ, CZC112CW4W, 3203, 616, MXL2342FBK, MXL2342F9N, MXL2342F9D, MXL221294Q, MXL221294Z, CZC12095LJ, CZC12175YY, MXL221293R, MXL221293Y, MXL2342F16, MXL2342FOC, MXL2342FB4, MXL2342FB9, MXL2342F9K, CZC1088DDM, CZC1099NF4, MXL3362KYB, CZC1077045, CZC107704M, CZC1077043, CZC107705D, 349, 2111600488, 2111601116, 482, 412, 2111601659, 2111601041, 2111601582, 251, 934, 305, 295, 2111600498, 217, 527, 2111600927, 247, 431, 2111601322, 2111600711, 455, 256, 268, 744, 795, 800, 64, 2111601489, 685, 2111600884, 2111600887, 629, 2111600641, 2111601079, 2111601443, 2111601444, 1104, 1133, 812, 2111601067, 571, 2111600465, 2111600628, 2111600809, 1195, 2111601172, 2111601176, 168, 2111600797, 2111600664, 195, 196, 780, 781, 69, 2111600764, 2111601312, 2111600814, 42, 129, 130, 2111600936, 2111600794, 105, 2111601478, 2111600759, 2111601677, 2111601338, 496, 1155, 1156, 2111601612, 2111601613, 65, 62, 2111601229, 480, 983, 206, 1151, 2111600934, 187, 2111601628, 448, 831, 832, 833, 2111601039, 970, 971, 972, 973, 2111601409, 2111601464, 2111601357, 1126, 357, 48, 2111600567, 2111601040, 953, 87, 259, 2111600694, 2111600791, 2111600924, 681, 694, 24, 25, 1088, 1173, 2111601091, 2111600656, 2111600568, 2111600578, 2111600817, 2111600778, 324, 535, 2111600769, 2111601672, 1135, 2111600433, 646, 1140, 2111601431, 2111601436, 2111601437, 2111601438, 2111601439, 889, 101, 608, 609, 892, 565, 821, 759, 335, 1167, 2111600468, 7, 1032, 1033, 1160, 2111601675, 2111601701, 2111601702, 590, 986, 987, 988, 989, 990, 1040, 2111601143, 2111601273, 395, 2111600551, 2111600611, 2111601493, 2111601494, 2111601495, 2111600613, 2111601221, 643, 2111601370, 729, 730, 731, 2111600635, 1137, 1015, 123, 124, 125, 2111600955, 2111600956, 433, 1106, 204, 834, 2111600684, 873, 998, 2111601213, 2111601255, 2111601332, 2111601323, 2111601204, 203, 2111601706, 2111601707, 2, 3, 2111601327, 2111601681, 262, 57, 2111601175, 150, 151, 152, 138, 139, 145, 156, 300, 980, 2111600495, 2111601220, 2111601154, 2111601798, 613, 614, 2111600763, 2111601165, 2111601235, 283, 539, 2111601002, 182, 337, 343, 344, 345, 620, 2111600445, 1161, 86, 282, 2111600777, 2111601725, 2111601726, 2111601727, 2111601728, 2111600583, 2111600588, 2111600589, 2111600590, 2111600564, 655, 656, 2111600970, 132, 2111601321, 814, 575, 611, 169, 191, 212, 2111601103, 2111601104, 146, 2111601584, 948, 2111601253, 1147, 490, 2111600614, 2111601550, 207, 1141, 157, 598, 2111601248, 2111600451, 192, 188, 189, 190, 2111600692, 2111600963, 2111600964, 2111600965, 2111600966, 763, 776, 263, 1020, 1021, 1022, 841, 2111600651, 310, 311, 2111600824, 2111600825, 278, 373, 2111600693, 93, 612, 11, 186, 793, 706, 2111600659, 2111600660, 653, 961, 2111601446, 898, 665, 2111600627, 2111600463, 662, 1086, 1162, 2111600541, 2111600479, 2111600480, 2111601720, 530, 607, 339, 2111601054, 119, 120, 2111600658, 756, 2111600992, 720, 633, 725, 377, 384, 2111600602, 2111600668, 2111601652, 2111600560, 2111600846, 599, 491, 288, 950, 606, 143, 667, 135, 1039, 82, 2111600525, 2111600530, 2111601250, 159, 2111600499, 468, 2111601547, 658, 2111601319, 1037 600, 1197, 83, 78, 2111600545, 2111600554, 2111601249, 1007, 2111601688.

Why it was recalled

Potential for pressure wave data synchronization from two devices may not be correct.

Root cause (FDA determination)

Component design/selection

Action the firm took

Consignees were mailed an URGENT Medical Device Correction notice, dated 4/30/24. Consignees are instructed to keep the provided notification with the documentation of affected systems until Philips implements the software correction, follow the provided instructions when connecting the pressure wire to the FM-PIM and refer to the FM Patient Interface Module (Option Manual, Chapters 3 and 5), and circulate the provided notification to all users of the system. In the case that steps described in the notification are not executed and/or the described issue is observed, perform the normalization procedure in accordance with Section 6.9 of the IFU for the Philips Hemodynamic Application. Consignees are to complete and return the provided response form within 30 days of receipt. Customers with any questions are to contact Philips Customer Care Solutions Center at 1-800-722-9377. Philips will install a software update to correct this issue and will contact consignees to schedule the onsite visit to perform the upgrade.

Recalling firm

Firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Distribution

Distribution pattern: Worldwide distribution - US Nationwide in the states of CA, IN, OR and the countries of Argentina, Australia, Austria, Bangladesh, Belgium, Bulgaria, Chile, Costa Rica, C¿te D'Ivoire, Czech Republic, Ecuador, France, Germany, Gibraltar, Greece, Hungary, India, Ireland, Italy, Malaysia, Martinique, Netherlands, New Zealand, Oman, Pakistan, Panama, Poland, R¿union, Russian Federation, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Sri Lanka, Switzerland, Thailand, Ukraine, United Kingdom.

Timeline

Recall initiated: 2024-05-02
Posted by FDA: 2024-05-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #207659. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.