Device recall
Z-1194-2010: Philips Heartstart (HS1) Onsite Automated External Defibrillator (AED) Catalog…
FDA device recall · Class II · Philips Medical Systems
Key facts
| Recall number (Z-number) | Z-1194-2010 |
|---|---|
| Recall event | 53816 |
| Product | Philips Heartstart (HS1) Onsite Automated External Defibrillator (AED) Catalog number M5066A |
| Product code | MKJ |
| Recalling firm | Philips Medical Systems |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 23, 2013 |
| 510(k) numbers | K020715 |
| FEI number | 1000524572 |
At a glance
- 1–9 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