—#136135

Product

EPIQ 5 Ultrasound System versions 1.3.2 or lower, WITHOUT the Pediatric Cardiology option, Model: EPIQ 5G, EPIC 5C, EPIQ 5W.Catalog Number: 795204 / 795205. Part Number: 989605408541 With 453561736761 (1.1) 453561750041 (1.1.1) 453561753651 (1.1.2) 453561772231 (1.2) 453561772611 (1.2.1) 453561786571 (1.2.2) 453561785081 (1.3) 453561800581 (1.3.1) 453561805181 (1.3.2) Diagnostic ultrasound imaging and fluid flow analysis.

FDA product code: IYN — System, Imaging, Pulsed Doppler, Ultrasonic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K132304
Affected lot / code info: ********************SYSTEM BASE ID IN THE US***************************** US114C0207, US114C0208, US114C0209, US114C0287, US114C0308, US114C0323, US114C0330, US114C0445, US114C0713, US114C0714, US114C0731, US115C0139, US115C0464, US115C0465, US115C0470, US115C0471, US115C0537, US115C0538, US115C0539, US115C0576, US115C0607, US214C0042, US214C0084, US214C0103, US214C0104, US214C0105, US214C0141, US214C0142, US214C0162, US214C0180, US214C0434, US215C0068, US215C0069, US215C0070, US215C0072, US215C0073, US215C0074, US215C0171, US215C0172, US215C0178, US215C0179, US215C0180, US215C0306, US215C0307, US215C0308, US215C0406, US215C0407, US215C0449, US215C0450, US215C0512, US215C0513, US215C0514, US215C0516, US215C0534, US215C0535, US215C0538, US215C0539, US215C0571, US215C0572, US215C0573, US215C0615, US215C0616, US215C0617, US215C0618, US215C0619, US215C0620, US215C0624, US215C0625, US215C0626, US215C0627, US215C0713, US215C0714, US215C0715, US215C0716, US215C0717, 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USD14C0756, USD14C0757, USD14C0762, USD14C0763, USD14C0764, USD14C0765, USD14C0877, USD14C0878, USD14C0879, USD14C0880, USD14C0881, USD14C0882, USD14C0883, USD14C0884, USD14C0885, USD14C0965, USD14C0966, USD14C0967, USD14C0968, USD14C0969, USD14C0970, USD14C0971, USD14C1019, USD14C1020, USD14C1021, USD14C1022, USD14C1023, USD14C1041, USD14C1042, USD14C1043, USN13C0341, USN13C0342, USN13C0394, USN13C0395, USN13C0396, USN13C0458, USN13C0463, USN13C0576, USN13C0577, USN13C0578, USN14C0032, USN14C0033, USN14C0034, USN14C0035, USN14C0036, USN14C0039, USN14C0103, USN14C0185, USN14C0186, USN14C0240, USN14C0366, USN14C0367, USN14C0380, USN14C0408, USN14C0418, USN14C0442, USN14C0464, USN14C0467, USN14C0468, USN14C0471, USN14C0472, USN14C0535, USN14C0536, USN14C0696, USN14C0697, USN14C0779, USN14C0886, USN14C0887, USN14C0943, USN14C0944, USN14C0945, USO13C0118, USO13C0119, USO13C0120, USO13C0346, USO13C0347, USO13C0348, USO13C0349, USO13C0351, USO13C0355, USO13C0356, USO13C0357, USO13C0380, 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*********************SYSTEM BASE ID IN CANANA**************************** US115C0433, US115C0495, US115C0496, US115C0497, US115C0498, US115C0499, US115C0571, US215C0348, US215C0566, US215C0567, US215C0679, US215C1042, US315C0090, US315C0404, US315C0405, US315C0406, US414C0604, US714C0076, US714C0297, US814C0111, US914C0200, USD14C0156, USN14C0382, USN14C0383, USN14C0384, USO14C0511, USO14C0512, and USO14C0566. ********************SYSTEM BASE ID IN OTHER COUNTRIES****************** US114B0005, US114B0006, US114C0081, US114C0082, US114C0107, US114C0110, US114C0143, US114C0144, US114C0145, US114C0146, US114C0147, US114C0148, US114C0192, US114C0193, US114C0194, US114C0211, US114C0238, US114C0309, US114C0320, US114C0348, US114C0363, US114C0366, US114C0408, US114C0409, US114C0442, US114C0446, US114C0532, US115C0017, US115C0052, US115C0053, US115C0054, US115C0100, US115C0101, US115C0137, US115C0138, US115C0141, US115C0178, US115C0179, US115C0180, US115C0181, US115C0212, US115C0213, 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US914C0960, USD13C0032, USD13C0037, USD13C0069, USD13C0074, USD13C0232, USD13C0238, USD13C0259, USD13C0260, USD13C0261, USD13C0262, USD13C0289, USD13C0290, USD13C0364, USD13C0444, USD13C0727, USD13C0728, USD13C0730, USD13C0731, USD13C0732, USD13C0733, USD13C0734, USD13C0786, USD13C0787, USD14C0040, USD14C0041, USD14C0042, USD14C0043, USD14C0044, USD14C0045, USD14C0046, USD14C0112, USD14C0113, USD14C0155, USD14C0157, USD14C0158, USD14C0159, USD14C0160, USD14C0161, USD14C0162, USD14C0163, USD14C0164, USD14C0280, USD14C0282, USD14C0283, USD14C0286, USD14C0287, USD14C0364, USD14C0365, USD14C0366, USD14C0367, USD14C0399, USD14C0401, USD14C0409, USD14C0475, USD14C0489, USD14C0517, USD14C0518, USD14C0519, USD14C0520, USD14C0521, USD14C0659, USD14C0665, USD14C0666, USD14C0667, USD14C0668, USN13C0245, USN13C0309, USN13C0310, USN13C0311, USN13C0312, USN13C0313, USN13C0378, USN13C0459, USN13C0462, USN13C0470, USN13C0498, USN13C0500, USN13C0503, USN13C0505, USN13C0531, USN13C0594, USN13C0659, 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USO13C0686, USO14C0029, USO14C0030, USO14C0031, USO14C0032, USO14C0033, USO14C0035, USO14C0036, USO14C0037, USO14C0038, USO14C0039, USO14C0040, USO14C0093, USO14C0094, USO14C0123, USO14C0124, USO14C0277, USO14C0339, USO14C0376, USO14C0438, USO14C0439, USO14C0476, USO14C0477, USO14C0479, USO14C0514, USO14C0515, USO14C0516, USO14C0565, USO14C0567, USO14C0568, USO14C0569, USO14C0607, USO14C0608, USO14C0611, USO14C0612, USO14C0659, USO14C0667, USO14C0718, USO14C0719, USO14C0720, USO14C0763, USO14C0803, USO14C0804, USO14C0844, USO14C0923, USO14C0924, USO14C1115, USO14C1116, USO14C1181, and USO14C1182.

Why it was recalled

When EPIQ 5 Ultrasound System, WITHOUT the Pediatric Cardiology option, is set up to "Metric" and weight and/or height is entered, a unit conversion error may result in the incorrect display of their values and incorrect calculation of the patients Body Surface Area (BSA).

Root cause (FDA determination)

Software design

Action the firm took

Philips sent the Urgent-Medical Device Correction-Philips Model EPIQ5 Ultrasound system and the Urgent-Medical Device Correction-Philips Model EPIQ7 Ultrasound system letters, both dated 2015 APR 14, to their US consignees. Philips sent the Urgent-Field Safety Notice-Philips Model EPIQ5 Ultrasound system letter and the Urgent-Field Safety Notice-Philips Model EPIQ7 Ultrasound system letter (both letters dated 2015 APRIL 14) to their foreign consignees. The EPIQ5 or EPIQ7 Ultrasound systems WITHOUT the Pediatric Cardiology option are affected. Philips issued two Field Change Orders (FCO) to their Field Service Engineer to install upgraded software: -FCO 79500340 for EPIQ5 -FCO 79500341 for EPIQ7 Customers with questions can call Philips Customer Service at 1-800-722-9377. Field Service Engineers (FSE) to install software version 1.3.3 per FCO 79500340 instructions for EPIQ5 5 and per FCO 79500341 instructions for EPIQ7.

Recalling firm

Firm: Philips Ultrasound, Inc.
Address: 22100 Bothell Everett Hwy, Bothell, Washington 98021-8431

Distribution

Distribution pattern: Worldwide Distribution

Timeline

Recall initiated: 2015-04-14
Posted by FDA: 2015-05-19
Terminated: 2016-08-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #136135. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.