FDA Device recall Z-2160-2021
OEC 3D Imaging, Image-Intensified Fluoroscopic X-Ray System, Mobile - Product Usage: designed to provide fluoroscopic and digital spot imag…
- FDA Device
- Class II
- terminated
- Published 2021-08-04
On 2021-08-04 the FDA classified a Class II recall of OEC 3D Imaging, Image-Intensified Fluoroscopic X-Ray System, Mobile - Product Usage: designed to provide fluoroscopic and digital spot imag… by Ge Oec Medical Systems, citing there is a potential that the coin cell battery used to monitor X-Ray tube temperature may deplete early causing the system to become inoperable.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2160-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-06-10 |
| Published | 2021-08-04 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ge Oec Medical Systems |
| Distribution | US |
Product
OEC 3D Imaging, Image-Intensified Fluoroscopic X-Ray System, Mobile - Product Usage: designed to provide fluoroscopic and digital spot images of adult and pediatric populations during diagnostic, interventional, and surgical procedures
Reason
There is a potential that the coin cell battery used to monitor X-Ray tube temperature may deplete early causing the system to become inoperable.
Identifiers
| code_info | All OEC 3D Systems |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Other recalls by Ge Oec Medical Systems
- OEC 9800 REF Image-Intensified Fluoroscopic X-Ray System, Mobile
FDA Device · Class II · 2024-12-25 · Ge Oec Medical Systems - OEC Elite REF Image-Intensified Fluoroscopic X-Ray System, Mobile
FDA Device · Class II · 2024-12-25 · Ge Oec Medical Systems - OEC 3D REF Image-Intensified Fluoroscopic X-Ray System, Mobile
FDA Device · Class II · 2024-12-25 · Ge Oec Medical Systems - OEC 9900 REF Image-Intensified Fluoroscopic X-Ray System, Mobile
FDA Device · Class II · 2024-12-25 · Ge Oec Medical Systems - OEC Flexiview 8800 Systems with 9-inch Image Intensifier
FDA Device · Class II · 2023-08-09 · Ge Oec Medical Systems
All Ge Oec Medical Systems recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2160-2021%22
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