Home / Recalls / Philips Medical Systems (Cleveland) Inc / Z-2191-2019

Z-2191-2019 Class II Terminated

Recalled by Philips Medical Systems (Cleveland) Inc — Cleveland, OH

Recall Details

Product Type
Devices
Report Date
August 14, 2019
Initiation Date
June 24, 2019
Termination Date
October 6, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product 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

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

Other recalls by Philips Medical Systems (Cleveland) Inc

  • Z-2570-2025 Class II — Pinnacle Radiation Therapy Planning System: Multimodality Simulation Workspac (August 5, 2025)
  • Z-2239-2025 Class II — Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software (July 17, 2025)
  • Z-1744-2022 Class II — Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237. (August 30, 2022)
  • Z-0215-2020 Class I — Forte Gamma Camera System is intended to produce images depicting the anatomical (September 19, 2019)
  • Z-0216-2020 Class I — Forte Gamma Camera System is intended to produce images depicting the anatomical (September 19, 2019)
  • Z-0214-2020 Class I — Forte Gamma Camera System is intended to produce images depicting the anatomical (September 19, 2019)
  • Z-0217-2020 Class I — Forte Gamma Camera System is intended to produce images depicting the anatomical (September 19, 2019)
  • Z-0213-2020 Class I — Forte Gamma Camera System is intended to produce images depicting the anatomical (September 19, 2019)
  • Z-2190-2019 Class II — iCT SP Model # 728311, computed tomography x-ray system (June 24, 2019)
  • Z-2189-2019 Class II — iCT, Model # 728306, computed tomography x-ray system (June 24, 2019)