Reported Feb 15, 2023 · Ongoing
GE Nuclear Medicine 600/800 series systems, specifically
Ge Medical Systems Israel, Functional Imaging
High riskUsing this product could cause serious injury, illness or death — stop using it now.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 Nuclear Medicine 600/800 series systems, specifically
7 of 7 products
| # | Product as published |
|---|---|
| 1 | BRIVO B615 3/8 inch DHP BJG NR |
| 2 | BRIVO 615 3/8 inch |
| 3 | BRIVO B615 3/8 inch DHP BJG NR |
| 4 | B615 with new rotor |
| 5 | BRIVO B615 3/8 inch BJG |
| 6 | BRIVO B615 3/8 inch DHP BJG NR |
| 7 | B615 with new rotor; Emission Computed Tomography System |
- Lot codes and dates
7 of 7 products
Products covered by this recall Model / number Product as published 5376204-16UDI/DI Not Applicable, Serial Numbers: NT2QG1900001BH 5376204-16BRIVO 615 3/8 inch: , UDI/DI To be provided, Serial Numbers: NT2QG2000002BH 5376204-16BRIVO B615 3/8 inch DHP BJG NR: , UDI/DI Not Applicable, Serial Numbers: NT2QG2000001BH 5376204-16B615 with new rotor: , UDI/DI To be provided, Serial Numbers: NT2QG1900002BH 5376204-16BRIVO B615 3/8 inch BJG: , UDI/DI Not Applicable, Serial Numbers: NT2QG1800001BH H2402MPBRIVO B615 3/8 inch DHP BJG NR: , UDI/DI To be provided, Serial Numbers: 00000168527HL0 — B615 with new rotor: Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT2QG2000003BH - Amount recalled
- 7 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Stop using this product now
A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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