FDA Device recall Z-2275-2023
OEC Flexiview 8800 Systems with 9-inch Image Intensifier
- FDA Device
- Class II
- ongoing
- Published 2023-08-09
On 2023-08-09 the FDA classified a Class II recall of OEC Flexiview 8800 Systems with 9-inch Image Intensifier by Ge Oec Medical Systems, citing image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved, which may result in t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2275-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-05-15 |
| Published | 2023-08-09 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ge Oec Medical Systems |
| Distribution | US |
Product
OEC Flexiview 8800 Systems with 9-inch Image Intensifier
Reason
Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved, which may result in the image intensifier falling, which could lead to injuries such as fractures, hematoma, contusion, bruise, pain.
Identifiers
| code_info | Serial Numbers: 3228PU4, 6936PU9 |
|---|
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-2275-2023%22
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