Drug recall
Field Upgrade Kits: P/N 5451208 RIU, 9 INCH, TOSHIBA; P/N 5485304 SERVICE PART, IMAGE INTENSIFIER, 9 INCH…
FDA recall event 92504 · Class II · GE OEC Medical Systems, Inc
Key facts
| Event ID | 92504 |
|---|---|
| Recall numbers | Z-2275-2023, Z-2276-2023, Z-2277-2023, Z-2278-2023, Z-2279-2023 |
| Recalling firm | GE OEC Medical Systems, Inc |
| Product type | Devices |
| Products | Field Upgrade Kits: P/N 5451208 RIU, 9 INCH, TOSHIBA; P/N 5485304 SERVICE PART, IMAGE INTENSIFIER, 9 INCH, TOSHIBA; P/N 5761613 SERVICE PART, IMAGE INTENSIFIER, 9 INCH - used with OEC Flexiview 8800…, OEC 9800 Systems with 9-inch Image Intensifier, OEC 9900 Systems with 9-inch Image Intensifier, OEC Elite Systems with 9-inch Image Intensifier, OEC Flexiview 8800 Systems with 9-inch Image Intensifier |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | 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… |
| Initiation date | May 15, 2023 |
| Report date | Aug 9, 2023 |
| City | Salt Lake City |
| State | UT |
| Country | United States |
| FEI number | 1720753 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: