Reported Jan 22, 2025 · Ongoing
GE Healthcare Brivo NM 615, Model/Catalog Numbers: 1) 5376204-15, 2) H2401MA, 3) H3100TA; System, Tomography, Computed,…
Ge Medical Systems Israel, Functional Imaging
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING · 4, Hayozma St · Tirat Carmel · N/A
Is this the product you have?
- GE Healthcare Brivo NM 615
- Model/Catalog Numbers1) 5376204-15, 2) H2401MA, 3) H3100TA; System, Tomography, Computed, Emission
- Lot codes and dates
113 of 113 products
Products covered by this recall # Barcodes Product as published 1 00840682145503UDI/DI 00840682145503, System ID 502629NMGD, Serial Number NT2UG2100002BH 2 00840682117869UDI/DI 00840682117869, System ID 509455BRIVO, Serial Number NT24G1700010BH, UDI/DI N/A, System ID 248544D630, Serial Number NT2QG1900003BH\NT2UG2100001BH. 2) H2401MA: UDI/DI Not Available, System ID 501552D615, Serial Number NT24G1600023 3 100035454149100035454149UDI/DI Not Available, System ID 100035454149, Serial Number T2CG15015/100035454149 4 UDI/DI Not Available, System ID 337643NM, Serial Number NT24G1600021 5 UDI/DI Not Available, System ID 718963B615, Serial Number NT24G1700009 6 UDI/DI Not Available, System ID Not Available, Serial Number NT24G1600020 7 UDI/DI Not Available, System ID 509455BRIVO, Serial Number NT24G1700010 8 UDI/DI Not Available, System ID 509455BRIVO, Serial Number NT24G1800001 9 00840682117869UDI/DI (01)00840682117869(11)17060021NT24G1700003BH, System ID NM6583AR, Serial Number NT24G1700003 10 00840682117869UDI/DI (01)00840682117869(11)17090021NT24G1700006BH, System ID NT24G1700006BH, Serial Number NT24G1700006 11 00840682117869UDI/DI (01)00840682117869(11)17080021NT24G1700004BH, System ID NT24G1700004BH, Serial Number NT24G1700004 12 UDI/DI Not Available, System ID Not Available, Serial Number NT24G1700008 13 UDI/DI Not Available, System ID CS1052NM10, Serial Number T2CG15010/166BH9 14 UDI/DI Not Available, System ID DK1043NM01, Serial Number T2CG15009/163BH6 15 UDI/DI Not Available, System ID EG2559NM01, Serial Number NT24G1700001 16 UDI/DI Not Available, System ID M4143529, Serial Number T2CG16018/187BH5 17 UDI/DI Not Available, System ID 083026108252217, Serial Number T2CG16019/232BH9 18 UDI/DI Not Available, System ID 083026108252217, Serial Number NT24G1700005 19 UDI/DI Not Available, System ID 083026861420919, Serial Number NT24G1800007 20 UDI/DI Not Available, System ID Not Available, Serial Number T2CG13006/127BH1 - Amount recalled
- 116 units
This recall covers 13 products
The agency filed one notice per product. You are reading one of them; the other 12 are below.
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Ge Medical Systems Israel, Functional Imaging recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.