Z-0894-2025Class II
GE Healthcare Discovery NM/CT 670 ES, Model/Catalog Numbers: 1) H3100XF ; System, Tomography, Computed...
GE Medical Systems Israel, Functional Imaging / initiated 2024-12-18 / Open, Classified / root cause: packaging
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING began a recall of GE Healthcare Discovery NM/CT 670 ES, Model/Catalog Numbers: 1) H3100XF ; System, Tomography, Computed, Emission on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Open, Classified, and MDM tags the root cause as packaging.
Recall record
- Recall number
- Z-0894-2025
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- GE Medical Systems Israel, Functional Imaging
- Product
- GE Healthcare Discovery NM/CT 670 ES, Model/Catalog Numbers: 1) H3100XF ; System, Tomography, Computed, Emission
- Product code
- KPS System, Tomography, Computed, Emission
- 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.
- Root cause tag
- packaging
- FDA root cause
- Package design/selection
- Action
- GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 12/18/2024. The notice explained the safety issue and requested the following actions be taken: There are two populations potentially affected by this notification: NOTE: Specific serial numbers of the following affected systems: Infinia Nuclear Medicine Systems: Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4; VG Nuclear Medicine systems: Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH; Brivo NM 615; Discovery NM 630; Discovery NM/CT 670, Discovery NM/CT 670 ES, Discovery NM/CT 670 DR, Discovery NM/CT 670 PRO, Discovery NM/CT 670 CZT; Optima NM/CT 640. For Serial Numbers listed in Appendix A of this letter: GE HealthCare requests that you STOP USING the system until GE HealthCare has inspected and if necessary, corrected your system and provided you with a letter indicating the system can be returned to clinical use. GE HealthCare has determined that these systems could have previously been transported or relocated without proper detector support. For Serial Numbers listed in Appendix B of this letter: You can continue to use your system, as GE HealthCare has determined that these systems have not previously been transported or relocated without proper detector support. For Serial Numbers listed in either Appendix A or Appendix B of this letter: GE HealthCare requests that you DO NOT physically relocate or transport your system from its current location. If you need to move or transport your system, please email GE HealthCare at [email protected] to receive specific instructions to follow before moving the system. When emailing this address, please provide the following information: " System serial number " Current system location " The reason for the move or transport, and subsequent destination Do not proceed with a physical relocation or transport of your system until you have received these instructions and taken the actions descri
- Quantity in commerce
- 17 units
- Distribution
- Worldwide
- Product codes and lots
- 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.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0888-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0889-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0890-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0891-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0892-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0893-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0894-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0895-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0896-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0897-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0898-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0899-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0900-2025 | Class II | Ongoing | Voluntary: Firm initiated |
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