Philips HeartStart XL M4735A Defibrillator/Monitors — Class II medical device recall Z-0011-2013

Terminated recall by Philips Healthcare Inc., reported 2012-10-10, distributed nationwide. HeartStart XL Defibrillator/Monitor (M4735A) used on a patient when AC power is not in use, with a battery tha

Recall number	`Z-0011-2013`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Philips Healthcare Inc., Andover, MA, United States
Recall initiated	2012-09-11
Classified	2012-10-04
Reported by FDA	2012-10-10
Terminated	2020-08-27
Distributed	Nationwide (US)
Countries outside the US	AE, AU, BD, BE, BR, CA, CH, CN, CO, CY, CZ, DE, ES, FI, FR, GB, HK, HU, ID, IE, IL, IN, IT, JO, JP, KE, KR, KW, LB, MX, MY, NL, NO, OM, PE, PH, PL, PT, RO, SA, SE, SG, SI, TH, TR, TW, VN, ZA
Quantity	2,500 units
Reason classes	device malfunction

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 for recall

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.

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-0011-2013. 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.