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GE Healthcare Discovery NM/CT 670 CZT, Model/Catalog Numbers recallZ-0895-2025 · Ge Medical Systems Israel, Functional Imaging · initiated Dec 18, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Ge Medical Systems Israel, Functional Imaging or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Package design/selection

What the company is doing

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

Recall details

Recall number
Z-0895-2025
Status
Open, Classified
Initiated by the company
Dec 18, 2024
Posted by the FDA
Jan 10, 2025
Recalling firm
Ge Medical Systems Israel, Functional Imaging
Quantity
8 units
Product code
KPS
FDA submissions
K093514
Distribution
Worldwide

Product description

GE Healthcare Discovery NM/CT 670 CZT, Model/Catalog Numbers: 1) H3906AB; System, Tomography, Computed, Emission

Code information (models, lots, serial numbers)

1) H3906AB: UDI/DI 840682121446, System ID UX2305NU03, Serial Number CZTV29005; UDI/DI 840682121446, System ID M4166103, Serial Number CZTV29006; UDI/DI 840682121446, System ID 00243NUC22, Serial Number CZTW29008; UDI/DI 840682121446, System ID 00222NUC07, Serial Number CZTW29009; UDI/DI N/A, System ID 604875D670B, Serial Number CZTW29007; UDI/DI N/A, System ID NT6200, Serial Number AD7W38007; UDI/DI N/A, System ID NT6201, Serial Number AD7X38017; UDI/DI N/A, System ID NT6100, Serial Number AP7W37001.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

6 devices cleared under K093514 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 96079).

Sources and updates

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