Brilliance 64 Model # 728231, computed tomography x-ray system
Enforcement
- Recall Number
- Z-2191-2019
- Event ID
- 83365
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Philips Medical Systems (Cleveland) Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 14, 2019
- Initiation Date
- June 24, 2019
- Classification Date
- August 6, 2019
- Termination Date
- October 6, 2022
- Address
- 595 Miner Rd, N/A, Cleveland, OH, 44143-2131, United States
Description
Brilliance 64 Model # 728231, computed tomography x-ray system
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
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
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
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