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
6 of 6 products
| # | Product as published |
|---|---|
| 1 | OPTIMA O640 X 3/8 inch NR |
| 2 | DISCOVERY O640 X 3/8 inch |
| 3 | NM OPTIMA O640 X 3/8 inch |
| 4 | O640 NM Gantry 3/8 inch |
| 5 | O640 NM GANTRY FINAL ASSY |
| 6 | OPTIMA O640 X 3/8 inch; Emission Computed Tomography System |
- Lot codes and dates
10 of 10 products
Products covered by this recall Model / number Product as published 5376204-41UDI/DI Not Applicable, Serial Numbers: 64GY51002, 64GY51003, 64GY51004, 0000064GY51011, 64GY51005 H3101RLDISCOVERY O640X 3/8 inch: , UDI/DI Not Applicable, Serial Numbers: 64GY51021 — NM OPTIMA O640X3/8 inch: Catalog number To be provided, UDI/DI To be provided, Serial Numbers: 26043 5376204-41O640 NM Gantry 3/8 inch: , UDI/DI Not Applicable, Serial Numbers: 64GY51022 — UDI/DI Not Applicable, Serial Numbers: 64GY51024, 64GY51007, 64GY51019, 64GY51018, 64GY51016, 64GX51001, 64GY51006, 64GY51013, 64GZ51026, 64GY51025, 64GY51012, 64GY51023, 64GY51014, 64GZ51027 — UDI/DI To be provided, Serial Numbers: 64GY51008, 64GY51009, 64GY51020, 64GZ51028, 64GZ51030, 64GY51015, 64GY51011 H3100JZO640 NM GANTRY FINAL ASSY: , UDI/DI To be provided, Serial Numbers: ONMX26515 H3101RLOPTIMA O640X3/8 inch: , UDI/DI Not Applicable, Serial Numbers: 64GZ51029, 64GZ51031 5376204-41UDI/DI Not Applicable, Serial Numbers: 64GY51017 — UDI/DI To be provided, Serial Numbers: 64GY51010. - Amount recalled
- 34 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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