Device recall
Z-0586-2015: ADULT Radiotranslucent Electrode, Part number T100-PHILIPS, Rx ONLY, For use…
FDA device recall · Class I · Heart Sync, Inc.
Key facts
| Recall number (Z-number) | Z-0586-2015 |
|---|---|
| Recall event | 69875 |
| Product | ADULT Radiotranslucent Electrode, Part number T100-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical HeartStart Electrodes Plug Style Connector", Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring, Single use. |
| Product code | MKJ |
| Recalling firm | Heart Sync, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Nov 24, 2015 |
| 510(k) numbers | K080421 |
| FEI number | 1317188 |
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