Device recall
Z-0206-2015: Gel-E Donut: 92025-A (Extra Small), 92025-B (Small), 92025-C (Medium) and…
FDA device recall · Class I · Philips Medical Systems, Inc.
Key facts
| Recall number (Z-number) | Z-0206-2015 |
|---|---|
| Recall event | 69568 |
| Product | Gel-E Donut : 92025-A (Extra Small), 92025-B (Small), 92025-C (Medium) and Squishon 2 91033-2. The products are intended to support and cradle a baby's head and/or body. |
| Product code | FMP |
| Recalling firm | Philips Medical Systems, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Nov 29, 2016 |
| FEI number | 1218950 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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