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

FDA Device Recall #Z-2191-2019 — Class II — June 24, 2019

Recall Summary

Recall Number Z-2191-2019
Classification Class II — Moderate risk
Date Initiated June 24, 2019
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Philips Medical Systems (Cleveland) Inc
Location Cleveland, OH
Product Type Devices
Quantity 582

Product Description

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

Reason for Recall

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

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

Lot / Code Information

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

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Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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