Device recall
Z-2279-2023: Field Upgrade Kits: P/N 5451208 RIU, 9 INCH, TOSHIBA; P/N 5485304 SERVICE PART…
FDA device recall · Class II · GE OEC Medical Systems, Inc
Key facts
| Recall number (Z-number) | Z-2279-2023 |
|---|---|
| Recall event | 92504 |
| Product | 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, and OEC 9900 Systems |
| Product code | OXO |
| Recalling firm | GE OEC Medical Systems, Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K003837, K021049, K073543, K111551, K120613, K132027 |
| FEI number | 1720753 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database