Device recall
Z-0080-2022: Philips, HeartStart HS1 Home Defibrillator, Model # Model number: M5068A
FDA device recall · Class II · Philips North America LLC
Key facts
| Recall number (Z-number) | Z-0080-2022 |
|---|---|
| Recall event | 88637 |
| Product | Philips, HeartStart HS1 Home Defibrillator, Model # Model number: M5068A |
| Product code | MKJ |
| Recalling firm | Philips North America LLC |
| Recall class | Class II |
| Status | Open, Classified |
| PMA numbers | P160029 |
| FEI number | 1000524572 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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