CLASS II ONGOING Device recall · Reported 22 Jan 2025 · FDA Enforcement Report
GE Healthcare Infinia recalled by Ge Medical Systems Israel
GE Medical Systems Israel Functional Imaging is recalling GE Healthcare Infinia I. The recall was initiated on 18 Dec 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0888-2025
- FDA event ID
- 96079
- Recalling firm
- GE Medical Systems Israel Functional Imaging, Tirat Carmel
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 18 Dec 2024
- FDA classified
- 10 Jan 2025
- Reported
- 22 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 18 Dec 2024 | Recall initiated by company | |
| 10 Jan 2025 | Classified by FDA | +23 days |
| 22 Jan 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
Product as listed by the FDA
GE Healthcare Infinia I, Model/Catalog Numbers: 1) 5178728, 2) H3000WE, 3) H3000WM, 4) H3000YG; System, Tomography, Computed, Emission
Where it was distributed
Worldwide
Questions about this recall
Why was it recalled?
GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
Which lots are affected?
1) 5178728: UDI/DI N/A, System ID YN1200, Serial Number: 16179; System ID YN1650, Serial Number: 17339. 2) H3000WE: UDI/DI N/A, System ID 82426060010, Serial Number Not Available; System ID 82426080021, Serial Number Not Available; System ID 82426090035, Serial Number 18605; System ID 82426090037, Serial Number 18604; System ID 82426100057, Serial Number 19191; System ID 82426150036, Serial Number 18624; System ID 82426150038, Serial Number Not Available; System ID 82426180015, Serial Number 18611; System ID 082426010021, Serial Number 18644; System ID 082426030032, Serial Number 18627; System ID 082426050012, Serial Number 18629; System ID 082426070041, Serial Number 18639; System ID 082426090044, Serial Number 18652; System ID 082426100067, Serial Number 18648; System ID 082426100069, Serial Number 18641; System ID 082426120031, Serial Number 18656; System ID 082426120033, Serial Number 18650; System ID 082426140029, Serial Number 18628; System ID 082426140030, Serial Number 18647; System ID 082426150039, Serial Number 18651; System ID 082426150040, Serial Number 18657; System ID 082426160040, Serial Number 18442; System ID 082426160054, Serial Number 18645; System ID 082426170004, Serial Number 18649; System ID 082426190031, Serial Number 18646; System ID 082426210028, Serial Number 18655; System ID 082426230028, Serial Number 18653; System ID 082426250006, Serial Number 18637; System ID 671USNHINF, Serial Number 17799; System ID A5128757, Serial Number 17566; System ID 713794INF, Serial Number 17219; System ID 920794inf, Serial Number 16364. 3) H3000WM: UDI/DI N/A, System ID NM16353, Serial Number 16353; System ID YN1540, Serial Number 16335; System ID YN1555, Serial Number 16315. 4) H3000YG: UDI/DI N/A, System ID A5172908, Serial Number 16143.
Where was it sold?
Worldwide
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
12 other products · FDA event 96079This product is part of a recall event; the main page for the event is GE Healthcare Brivo NM recalled by Ge Medical Systems Israel.
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