CLASS II ONGOING Device recall · Reported 22 Jan 2025 · FDA Enforcement Report

GE Healthcare Discovery NM/CT 670 CZT recalled

GE Medical Systems Israel Functional Imaging is recalling GE Healthcare Discovery NM/CT 670 CZT. The recall was initiated on 18 Dec 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1) 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.

Quantity recalled8 units

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-0895-2025
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 CZT, Model/Catalog Numbers: 1) H3906AB; System, Tomography, Computed, Emission

Where it was distributed

Worldwide

Questions about this recall

Why was it recalled?

Which lots are affected?

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.

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 96079

This product is part of a recall event; the main page for the event is GE Healthcare Brivo NM recalled by Ge Medical Systems Israel.

Reported	Class	Recall	Company	Reason
22 Jan 2025	CLASS II	GE Healthcare Brivo NM recalled by Ge Medical Systems Israel	GE Medical Systems Israel Functional Imaging	Other
22 Jan 2025	CLASS II	GE Healthcare Infinia recalled by Ge Medical Systems Israel	GE Medical Systems Israel Functional Imaging	Other
22 Jan 2025	CLASS II	GE Healthcare Discovery NM/CT 670 DR recalled	GE Medical Systems Israel Functional Imaging	Other
22 Jan 2025	CLASS II	GE Healthcare Discovery NM/CT 670 ES recalled	GE Medical Systems Israel Functional Imaging	Other
22 Jan 2025	CLASS II	GE Healthcare Discovery NM/CT recalled by Ge Medical Systems Israel	GE Medical Systems Israel Functional Imaging	Other
22 Jan 2025	CLASS II	GE Healthcare Infinia I Hawkeye recalled by Ge Medical Systems Israel	GE Medical Systems Israel Functional Imaging	Other
22 Jan 2025	CLASS II	GE Healthcare Infinia II recalled by Ge Medical Systems Israel	GE Medical Systems Israel Functional Imaging	Other
22 Jan 2025	CLASS II	GE Healthcare Optima NM/CT recalled by Ge Medical Systems Israel	GE Medical Systems Israel Functional Imaging	Other
22 Jan 2025	CLASS II	GE Healthcare Infinia II Hawkeye recalled by Ge Medical Systems Israel	GE Medical Systems Israel Functional Imaging	Other
22 Jan 2025	CLASS II	GE Healthcare Discovery NM recalled by Ge Medical Systems Israel	GE Medical Systems Israel Functional Imaging	Other
22 Jan 2025	CLASS II	GE Healthcare Discovery NM/CT 670 PRO recalled	GE Medical Systems Israel Functional Imaging	Other
22 Jan 2025	CLASS II	GE Healthcare Varicam Millennium VG Discovery VH recalled	GE Medical Systems Israel Functional Imaging	Other

More recalls from GE Medical Systems Israel Functional Imaging

All 41

Reported	Class	Recall	Company	Reason	Where
28 Jan 2026Device	CLASS II	GE Healthcare Omni Legend, sold under the following names recalled	GE Medical Systems Israel Functional Imaging	Other	Nationwide
21 Jan 2026Device	CLASS II	Maxxus, System, Tomography, Computed, Emission recalled	GE Medical Systems Israel Functional Imaging	Other
21 Jan 2026Device	CLASS II	SMV DSX New Line, System, Tomography, Computed, Emission recalled	GE Medical Systems Israel Functional Imaging	Other
21 Jan 2026Device	CLASS II	SMV BodyTrack, System, Tomography, Computed, Emission recalled	GE Medical Systems Israel Functional Imaging	Other
21 Jan 2026Device	CLASS II	SMV DSI, System, Tomography, Computed, Emission recalled	GE Medical Systems Israel Functional Imaging	Other

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide