FDA Device recall Z-1056-2023
GE Nuclear Medicine 600/800 series systems, specifically: a) OPTIMA O640 X 3/8 inch NR, b) DISCOVERY O640 X 3/8 inch, c) NM OPTIMA O640 X 3…
- FDA Device
- Class I
- ongoing
- Published 2023-02-15
On 2023-02-15 the FDA classified a Class I recall of GE Nuclear Medicine 600/800 series systems, specifically: a) OPTIMA O640 X 3/8 inch NR, b) DISCOVERY O640 X 3/8 inch, c) NM OPTIMA O640 X 3… by Ge Medical Systems Israel Functional Imaging, citing A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1056-2023 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2022-12-19 |
| Published | 2023-02-15 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ge Medical Systems Israel Functional Imaging |
| Distribution | US |
Product
GE Nuclear Medicine 600/800 series systems, specifically: a) OPTIMA O640 X 3/8 inch NR, b) DISCOVERY O640 X 3/8 inch, c) NM OPTIMA O640 X 3/8 inch, d) O640 NM Gantry 3/8 inch, e) O640 NM GANTRY FINAL ASSY, f) OPTIMA O640 X 3/8 inch; Emission Computed Tomography System
Reason
A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.
Identifiers
| code_info | a) OPTIMA O640X3/8 inch NR: Catalog number 5376204-41, UDI/DI Not Applicable, Serial Numbers: 64GY51002, 64GY51003, 64…a) OPTIMA O640X3/8 inch NR: Catalog number 5376204-41, UDI/DI Not Applicable, Serial Numbers: 64GY51002, 64GY51003, 64GY51004, 0000064GY51011, 64GY51005; b) DISCOVERY O640X 3/8 inch: Catalog number H3101RL, UDI/DI Not Applicable, Serial Numbers: 64GY51021; c) NM OPTIMA O640X3/8 inch: Catalog number To be provided, UDI/DI To be provided, Serial Numbers: 26043; d) O640 NM Gantry 3/8 inch: Catalog number 5376204-41, 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; e) O640 NM GANTRY FINAL ASSY: Catalog number H3100JZ, UDI/DI To be provided, Serial Numbers: ONMX26515; f) OPTIMA O640X3/8 inch: Catalog number H3101RL, UDI/DI Not Applicable, Serial Numbers: 64GZ51029, 64GZ510 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1056-2023%22
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