CLASS II ONGOING Device recall · Reported 22 Jan 2025 · FDA Enforcement Report
GE Healthcare Discovery NM/CT 670 ES recalled
GE Medical Systems Israel Functional Imaging is recalling GE Healthcare Discovery NM/CT 670 ES. 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-0894-2025
- 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 Discovery NM/CT 670 ES, Model/Catalog Numbers: 1) H3100XF ; 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) H3100XF: UDI/DI N/A, System ID NT1011, Serial Number T2AG12009/ 88227HL4; UDI/DI N/A, System ID NT2002, Serial Number T2AG12011/ 89154HL9; UDI/DI N/A, System ID NT1009, Serial Number T2AG12013/ 90088HL6; UDI/DI N/A, System ID NT1003, Serial Number T2BG11001/ 79573HL2; UDI/DI N/A, System ID NT1004, Serial Number T2AG12003/ 79574HL0; UDI/DI N/A, System ID NT1005, Serial Number 84775HL6; UDI/DI N/A, System ID NT1020, Serial Number T2AG12012/ 89666HL2; UDI/DI N/A, System ID NT1016, Serial Number T2AG13020/ 96237HL3; UDI/DI N/A, System ID NT0002, Serial Number 106491HL4; UDI/DI N/A, System ID NT2004, Serial Number 105724HL9; UDI/DI N/A, System ID NT1012, Serial Number T2AG13016/ 93885HL2; UDI/DI N/A, System ID NT1012, Serial Number T2AG13017/ 93885HL2; UDI/DI N/A, System ID NT1013, Serial Number 94165HL8; UDI/DI N/A, System ID NT1010, Serial Number T2AG12008/ 87697HL9; UDI/DI N/A, System ID NT3001, Serial Number 85748HL2; UDI/DI N/A, System ID NT1017, Serial Number T2AG13027/ 104213HL4; UDI/DI N/A, System ID NT1015, Serial Number T2AG13018/ 94292HL0.
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.
More recalls from GE Medical Systems Israel Functional Imaging
All 41| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | GE Healthcare Omni Legend, sold under the following names recalled | GE Medical Systems Israel Functional Imaging | Other | Nationwide |
| Device | CLASS II | Maxxus, System, Tomography, Computed, Emission recalled | GE Medical Systems Israel Functional Imaging | Other | |
| Device | CLASS II | SMV DSX New Line, System, Tomography, Computed, Emission recalled | GE Medical Systems Israel Functional Imaging | Other | |
| Device | CLASS II | SMV BodyTrack, System, Tomography, Computed, Emission recalled | GE Medical Systems Israel Functional Imaging | Other | |
| Device | CLASS II | SMV DSI, System, Tomography, Computed, Emission recalled | GE Medical Systems Israel Functional Imaging | Other |
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