Device recall
Z-3081-2024: GE Panda iRES Warmer, Model/Catalog Numbers: 1) M1112198-01045518; 2)…
FDA device recall · Class II · Wipro GE Healthcare Private Ltd.
Key facts
| Recall number (Z-number) | Z-3081-2024 |
|---|---|
| Recall event | 95216 |
| Product | GE Panda iRES Warmer, Model/Catalog Numbers: 1) M1112198-01045518; 2) M1112198-01045579; 3) M1112198-01047148; 4) M1112198-01047271; 5) M1112198-01048731; 6) M1112198-01048740; 7) M1112198-01052386; 8) M1112198-01054697; 9) M1112198-01068942; 10) M1112198-01084972; 11) M1112198-01090848; 12)… |
| Product code | FMT |
| Recalling firm | Wipro GE Healthcare Private Ltd. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K201628 |
| FEI number | 3007734888 |
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