Device recall
Z-1232-2014: Philips HeartStart Home and OnSite (HS1) automated external defibrillators…
FDA device recall · Class II · Philips Medical Systems North America Inc.
Key facts
| Recall number (Z-number) | Z-1232-2014 |
|---|---|
| Recall event | 67612 |
| Product | Philips HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs). Product Usage: The models M5066A, M5067A, and M5068A are designed for use on a person in sudden cardiac arrest who is: -Unresponsive when shaken -Not breathing normally If in doubt, apply the pads. A training class in… |
| Product code | MKJ |
| Recalling firm | Philips Medical Systems North America Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 23, 2017 |
| 510(k) numbers | K020715, K040904 |
| 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