CLASS II ONGOING Device recall · Reported 22 Jan 2025 · FDA Enforcement Report
GE Healthcare Discovery NM/CT 670 DR recalled
GE Medical Systems Israel Functional Imaging is recalling GE Healthcare Discovery NM/CT 670 DR. 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-0892-2025
- 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 DR, Model/Catalog Numbers: 1) 5376204-70-56-2; 2) H2401AW; 3) H3100AN; 4) H3100BT; 5) H3100PX; 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) 5376204-70-56-2: UDI/DI N/A, System IDNT7007, Serial Number NT2JG1800001; UDI/DI N/A, System IDNT4014, Serial Number T2HG1700003/ 158624HL7; UDI/DI N/A, System IDNT4017, Serial Number 157120HL7; UDI/DI N/A, System IDNT7001, Serial Number 156620HL7; UDI/DI N/A, System IDNT7005, Serial Number 159731HL9. 2) H2401AW: UDI/DI 840682140898, System ID N/A, Serial Number NT2JG1800004; UDI/DI 840682140898, System ID N/A, Serial Number NT2JG1800005; UDI/DI 840682140898, System ID N/A, Serial Number NT2JG1800006; UDI/DI 840682140898, System ID N/A, Serial Number NT2JG1800007; UDI/DI 840682140898, System ID N/A, Serial Number NT2JG1800008; UDI/DI 840682140898, System ID N/A, Serial Number NT2JG1800009; UDI/DI 840682140898, System ID LY1198CT02, Serial Number NT2JG1800010; UDI/DI N/A, System ID N/A, Serial Number T2HG1700001; UDI/DI N/A, System ID N/A, Serial Number T2HG1700002; UDI/DI N/A, System ID N/A, Serial Number T2HG1800004; UDI/DI N/A, System ID N/A, Serial Number T2HG1800001; UDI/DI N/A, System ID N/A, Serial Number T2HG1800002; UDI/DI N/A, System ID N/A, Serial Number T2HG1800003; UDI/DI N/A, System ID N/A, Serial Number T2JG1800001. 3) H3100AN: UDI/DI 840682124393, System ID 501257D670, Serial Number DDRX34049; UDI/DI 840682124393, System ID 909558D670NM, Serial Number DDRX34058; UDI/DI 840682124393, System ID 215707D670, Serial Number DDRW34002; UDI/DI 840682124393, System ID Not Available, Serial Number DDRW34004; UDI/DI 840682124393, System ID 786257NMD670, Serial Number DDRW34005; UDI/DI 840682124393, System ID 773702NM670, Serial Number DDRW34006; UDI/DI 840682124393, System ID ZWL0680, Serial Number DDRW34007; UDI/DI 840682124393, System ID FI1019MN02, Serial Number DDRW34008; UDI/DI 840682124393, System ID 0850260162, Serial Number DDRW34009; UDI/DI 840682124393, System ID 450359D670, Serial Number DDRW34010; UDI/DI 840682124393, System ID FI1064NU02, Serial Number DDRW34011; UDI/DI 840682124393, System ID M40180135, Serial Number DDRW34012; UDI/DI 840682124393, System ID 541CMINM, Serial Number DDRW34013; UDI/DI 840682124393, System ID 030029NU08, Serial Number DDRW34014; UDI/DI 840682124393, System ID 832826NM, Serial Number DDRW34015; UDI/DI 840682124393, System ID 772332NU01, Serial Number DDRW34016; UDI/DI 840682124393, System ID 814269D670NM, Serial Number DDRW34017; UDI/DI 840682124393, System ID 519752D670, Serial Number DDRW34018; UDI/DI 840682124393, System ID E001NU21, Serial Number DDRW34019; UDI/DI 840682124393, System ID ENS0132, Serial Number DDRW34020; UDI/DI 840682124393, System ID FI1021MN03, Serial Number DDRW34021; UDI/DI 840682124393, System ID 708216NM670, Serial Number DDRW34023; UDI/DI 840682124393, System ID 450771D670, Serial Number DDRW34024; UDI/DI 840682124393, System ID 00361NUC11, Serial Number DDRW34025; UDI/DI 840682124393, System ID MPX57807, Serial Number DDRW34026; UDI/DI 840682124393, System ID CC0618NU15, Serial Number DDRW34027; UDI/DI 840682124393, System ID 83167403240, Serial Number DDRW34028; UDI/DI 840682124393, System ID B1768016, Serial Number DDRW34030; UDI/DI 840682124393, System ID Not Available, Serial Number DDRW34031; UDI/DI 840682124393, System ID 513584NM670, Serial Number DDRW34032; UDI/DI 840682124393, System ID 00432NUC07, Serial Number DDRW34033; UDI/DI 840682124393, System ID 00440NUC32, Serial Number DDRW34034; UDI/DI 840682124393, System ID A173433206, Serial Number DDRW34035; UDI/DI 840682124393, System ID Not Available, Serial Number DDRX34036; UDI/DI 840682124393, System ID 6073MI0009, Serial Number DDRX34037; UDI/DI 840682124393, System ID V1471127, Serial Number DDRX34039; UDI/DI 840682124393, System ID 414805DISC, Serial Number DDRX34041; UDI/DI 840682124393, System ID 450468D670, Serial Number DDRX34042; UDI/DI 840682124393, System ID 06184NUC07, Serial Number DDRX34043; UDI/DI 840682124393, System ID M4480271, Serial Number DDRX34044; UDI/DI 840682124393, System ID 414328DISC, Serial Number DDRX34045; UDI/DI 840682124393, System ID 415300D670, Serial Number DDRX34046; UDI/DI 840682124393, System ID M4038073, Serial Number DDRX34047; UDI/DI 840682124393, System ID 11018NUC14, Serial Number DDRX34051; UDI/DI 840682124393, System ID 083026282101818, Serial Number DDRX34052; UDI/DI 840682124393, System ID 0853260197, Serial Number DDRX34054; UDI/DI 840682124393, System ID 00362NUC04, Serial Number DDRX34055; UDI/DI N/A, System ID 650723D670, Serial Number DDRX34056; UDI/DI N/A, System ID 801545XEL1, Serial Number DDRX34038; UDI/DI N/A, System ID 802847SPEC670, Serial Number DDRW34003; UDI/DI N/A, System ID NMDDRX34053, Serial Number DDRX34053; UDI/DI N/A, System ID M4234247, Serial Number DDRW34001; UDI/DI N/A, System ID NT7002, Serial Number T2BG1700046/ DDRW34029; UDI/DI N/A, System ID NT7002, Serial Number DDRW34029. 4) H3100BT: UDI/DI 840682139359, System ID1000000606, Serial Number DRGX56002; UDI/DI 840682139359, System ID09953506, Serial Number DRGX56012. 5) H3100PX: UDI/DI 00840682124393, System ID 83169440013, Serial Number DDRW34022.
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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