Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2022-12-19 | Z-1057-2023 | Class I | Open, Classified | A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.Distribution: Worldwide distribution. US nationwide including Puerto Rico, Algeria, Argentina, Australia, Austria, Bahrain, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt, El Salvador, Ethiopia, Finland, France, Germany, Ghana, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Republic of Korea, Kuwait, Libya, Lithuania, Malaysia, Martinique, Mexico, Morocco, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Uzbekistan, and Vietnam. | 86 units | clearance family |
| 2020-12-10 | Z-0855-2021 | Class II | Open, Classified | GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.Distribution: Worldwide | 12 units | clearance family |
| 2020-08-14 | Z-2993-2020 | Class II | Terminated | Rotor bearing screws were found loose on detector.Distribution: USA : AR CT FL GA IL KS KY LA MA MD MI MN MO NE NJ NV NY OH OK RI SC TN TX VA VT WA WI OUS: ARGENTINA AUSTRIA BELGIUM BRAZIL Canada CHINA FRANCE GERMANY GREECE INDIA ISRAEL ITALY JAPAN Korea (Republic of) NETHERLANDS NORWAY PANAMA POLAND PORTUGAL Russia SPAIN SWEDEN SWITZERLAND TAIWAN THAILAND TURKEY UNITED KINGDOM VIETNAM | 15 units | clearance family |
| 2019-03-20 | Z-1258-2019 | Class II | Terminated | During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one detector mounting design redundancy.Distribution: US and Austria, Canada, Croatia, France, Germany, India, Italy, Japan, Republic of Korea, Netherlands, Poland, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, UK | 3 units | clearance family |
| 2019-03-20 | Z-1264-2019 | Class II | Terminated | During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one detector mounting design redundancy.Distribution: US and Austria, Canada, Croatia, France, Germany, India, Italy, Japan, Republic of Korea, Netherlands, Poland, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, UK | 16 units | clearance family |
| 2017-05-19 | Z-2195-2017 | Class II | Terminated | It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.Distribution: Worldwide Distribution - USA (nationwide) including Puerto Rico and to the countries of : Japan, Jordan, Kazakhstan, Korea ( Republic of) Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritania, Mexico, Moldova, Morocco, Nambia, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic of Serbia, Reunion, Romania, Russia, Rwanda, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain Sweden, Switzerland, Syria, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Vietam and Yemen. | 10,884 | clearance family |
Regulatory clearances
- 510(k)K153402Substantially equivalent (SESE) · 2016-01-21clearance family
Predicate lineage
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2010-01-12 | NAI | No action indicated | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING | 0 |
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