FDA Device recall Z-0011-2013
Philips HeartStart XL M4735A Defibrillator/Monitors, used with the M3516A batteries The Heart Start XL Defibrillator/Monitor is a fully fea…
- FDA Device
- Class II
- terminated
- Published 2012-10-10
On 2012-10-10 the FDA classified a Class II recall of Philips HeartStart XL M4735A Defibrillator/Monitors, used with the M3516A batteries The Heart Start XL Defibrillator/Monitor is a fully fea… by Philips Healthcare, citing heartStart XL Defibrillator/Monitor (M4735A) used on a patient when AC power is not in use, with a battery that may fail, the device may shut down unexpectedly without providing t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0011-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-09-11 |
| Published | 2012-10-10 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Philips Healthcare |
| Distribution | US |
Product
Philips HeartStart XL M4735A Defibrillator/Monitors, used with the M3516A batteries The Heart Start XL Defibrillator/Monitor is a fully featured, defibrillator intended for use by qualified medical personnel, trained in either Advanced Cardiac Life Support or in the operation of the device, in a hospital environment.
Reason
HeartStart XL Defibrillator/Monitor (M4735A) used on a patient when AC power is not in use, with a battery that may fail, the device may shut down unexpectedly without providing the user with a low battery warning message or audible tone.
Identifiers
| code_info | HeartStart XL battery M3516A labeled with Made in Taiwan and an R-2011-12 Date of Manufacture |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0011-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.