Device recall
Z-1137-2021: PHILIPS BATTERY, V60 14.4V, 11.0 Ah, 163 Wh, REF 1076374(1058272), LOT M94663-P1…
FDA device recall · Class II · Respironics California, LLC
Key facts
| Recall number (Z-number) | Z-1137-2021 |
|---|---|
| Recall event | 87314 |
| Product | PHILIPS BATTERY, V60 14.4V, 11.0 Ah, 163 Wh, REF 1076374(1058272), LOT M94663-P1 - Product Usage: The ventilator is intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories. |
| Product code | MNT |
| Recalling firm | Respironics California, LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K082660 |
| FEI number | 2518422 |
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