—#174970

Product

Brilliance 64 Model # 728231, computed tomography x-ray system

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K042293
Affected lot / code info: System Serial Number 335, 338, 1897, 4001, 4003, 4016, 4021, 9009, 9029-9030, 9033, 9035, 9038, 9040, 9045, 9047, 9048, 9052, 9054, 9056, 9058, 9062, 9064-9068, 9070-9077, 9080, 9086, 9087,9089, 9092, 9093, 9098, 9099, 9104- 9108, 9112, 9117 9120, 9121, 9127, 9134, 9138, 9140, 9148, 9159- 9160 9171, 9187, 9201, 9208, 9234, 9243, 9501, 9509 through 9608, 9610 through 10288, 10291 through 10327, 10330 through 10339, 10341 through 10808, 10811-10812, 29002, 29005, 29007, 29009, 29012, 29014, 29016-29018, 29020,29022, 29024, 29025-29027, 29032, 29035, 29037-29039, 29044-29045, 29047- 29049 29053- 29054, 29056- 29057, 29062, 29064-29066, 29068, 29081, 29086 29092, 29097, 29102, 29107, 29108, 29111, 29115, 29118, 29124, 29135 29138, 32065, 64045, 64051, 90029- 90031, 90041, 90046, 90047, 90054, 90056, 90058, 90062, 9006390066, 90069, 90072, 90078, 90079, 90081, 90082, 90085, 90086, 90087, 90089,90091, 90094, 90097, 90098, 90107, 90111, 90119, 90123-90124, 90128, 90131, 90135, 90136 90137, 90139, 90140, 90141, 90143, 90147, 90150, 90154, 90157, 90158, 90161,90163, 90167-90170, 90175,90177,90180, 90185, 90189,90199, 90205, 90213, 90218, 90223-90225, 90227, 90804, 91003, 95003, 95004, 95008, 95009, 95013- 95014 95017 through 95026, 95028, 95030 through 95061, 95063, 95069, 95071 through 95114, 95116-95118, 95130 through 95296, 95298 through 95476, 95478-95479, 95481 through 95529, 95531 through 95554, 95556 through 95566, 95568, 95570 through 95575, 95577 through 95584, 95586, 95588-95589, 95591through 95947, 122706, 320034, 760014, 6000861, 6001993, 6002294, 6002305, 6003273, 6003368, 6003844, 6003941, 200000618-1, 10003/11205, 10081, 10182EBW13108, 1155-16, 1157-09, 1157-10, 1158-05, 1190-02, 1339-09, 1343-02, 1347-04, 1348-01, 1349-01, 1350-02, 1OO82, 4101_45, 4272-08, 9208A, 95040, 95459, 95585/11737/80302, 9944, 95611, 95561/ISP80282

Why it was recalled

In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied

Root cause (FDA determination)

Other

Action the firm took

Philips Healthcare issued a Field Safety Notification (FSN)72800720/88200522 1. Identify affected product 2. There are 3 scenarios users may experience which result in identical images that are incorrectly labeled as phase tolerance images. A. When performing a Step and Shoot acquisition with phase tolerance selected, images may be reconstructed identically (a single phase), but are labeled as different phases. This occurs when Start Final Recon is selected prior to display of the ECG wave at the top of the acquisition window. B. When performing a Step and Shoot acquisition with phase tolerance selected, images may be reconstructed identically (a single phase), but are labeled as different phases. This occurs if ECG leads become disconnected mid-acquisition or when the acquisition is halted prematurely due to an application crash. C. By system design, in certain instances when a patient exhibits an arrhythmia or varying heart rate during a Step and Shoot acquisition, images from the acquisition following the heart rate variation, may be labeled in the incorrect phase 4. Determine whether you have a potentially affected system, then determine your AFFECTED PRODUCTS software version. To identify the software version of your product: Click the Help button, Select About and the software version is then displayed, Software versions 4.x, 3.x, and 2.x are potentially affected. 5. Take the Action listed in the field safety notice. Please retain a copy with the equipment Instruction for use. If you need any further information or support concerning this issue, please contact your local Philips representative: North America and Canada, contact the Customer Care Solutions Center (1-800-722-9377 and follow the prompts).

Recalling firm

Firm: Philips Medical Systems (Cleveland) Inc
Address: 595 Miner Rd, Cleveland, Ohio 44143-2131

Distribution

Distribution pattern: Worldwide distribution. US nationwide including Puerto Rico, Canada, Mexico, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Cambodia, Cayman Islands, Chile, China, Colombia, Cote D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Djibouti, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, French Polynesia, Gabon, Georgia, Germany, Ghana, Gibraltar, Greece, Greenland, Guyana, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malawi, Malaysia, Maldives, Mali, Malta, Martinique, Mauritius, Monaco, Mongolia, Morocco, Mozambique, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, State of Palestine, Panama, Peru, Philippines, Poland, Qatar, Reunion, Romania, Russian Federation, Rwanda, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Timor-Leste, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam, and Yemen

Timeline

Recall initiated: 2019-06-24
Posted by FDA: 2019-08-06
Terminated: 2022-10-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #174970. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.