Philips HeartStart XL — Class II medical device recall Z-1109-2014
Terminated recall by Philips Medical Systems, Inc., reported 2014-03-05, distributed nationwide. Philips HeartStart XL may experience a power board failure causing failure to defibrillate
| Recall number | Z-1109-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Medical Systems, Inc., Andover, MA, United States |
| Recall initiated | 2014-02-14 |
| Classified | 2014-02-26 |
| Reported by FDA | 2014-03-05 |
| Terminated | 2016-06-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BD, BE, BR, CA, CH, CN, CO, DE, ES, FI, FR, GB, HU, ID, IE, IN, IT, JP, KR, LK, MX, MY, NL, NP, PT, SG, TH, TW, VE, VN, ZA |
| Quantity | 5,234 units |
| Model numbers | M4735A |
Product
Philips HeartStart XL, Defibrillator/Monitor Model number M4735A Product Usage: The M4735A HeartStart XL Defibrillator/Monitor is for use in the hospital by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac life support, or defibrillation. It must be used by or on the order of a physician. When operating as a semi-automatic external defibrillator in AED Mode, the M4735A HeartStart XL Defibrillator/Monitor is suitable for use by medical personnel trained in basic life support that includes the use of an AED
Reason for recall
Philips HeartStart XL may experience a power board failure causing failure to defibrillate
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1109-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.