Z-0011-2013Class II

Philips HeartStart XL M4735A Defibrillator/Monitors, used with the M3516A batteries The Heart Start XL...

Name: Z-0011-2013 Philips HeartStart XL M4735A Defibrillator/Monitors, used with the M3516A batteries The Heart Start XL...
Creator: Philips Healthcare Inc.
Published: 2012-09-11
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2012-09-11 / Terminated / root cause: manufacturing process

FDA source

Philips Healthcare Inc. began a recall of Philips HeartStart XL M4735A Defibrillator/Monitors, used with the M3516A batteries The Heart Start XL Defibrillator/Monitor is a fully featured, defibrillator... on 2012-09-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0011-2013
Classification: Class II
Status: Terminated
Initiated: 2012-09-11
Posted: 2012-10-04
Terminated: 2020-08-27
Recalling firm: Philips North America LLC
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.
Product code: MKJ Automated External Defibrillators (Non-Wearable)
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm, Philips Healthcare, sent an "URGENT-MEDICAL DEVICE RECALL/Field Safety Notice" letter dated September 6, 2012 to its customers. The letter describes the product, problem and actions to be taken by the customer and also identifies what action Philips plans to take to remedy the issue. The customers were instructed to operate the XL and AC power instead of battery power alone; use a battery from a different date of manufacture (must not have the R-2011-12 date of manufacture code) if they need to operate the XL on battery power alone; and use an alternative source for treatment or therapy (i.e., backup defibrillator/monitor) if unable to operate with AC power alone or locate a battery with a different date of manufacture than that identified. Phillips will provide a replacement battery(s) to customers as soon as new production is available. If you need any further information or support concerning this issue, contact your local Philips representative or call Quality Specialists,Recalls at 978-687-1501 or email: [email protected].
Quantity in commerce: 2500 units
Distribution: Worldwide distribution: USA (Nationwide) and countries of: AUSTRALIA, BANGLADESH, BELGIUM, BRAZIL, CANADA, CHINA, COLOMBIA, CYPRUS, CZECH REPUBLIC, FINLAND, FRANCE, GERMANY HONG KONG, HUNGARY, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY JAPAN, JORDAN, KAZAKHSTAN, KENYA, KOREA, REPUBLIC OF KUWAIT LEBANON, MACAU, MALAYSIA, MEXICO, NAMIBIA, NETHERLANDS, NORWAY, OMAN, PERU, PHILIPPINES, POLAND, PORTUGAL, ROMANIA RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, PROVINCE OF CHINA, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, and VIET NAM.
Product codes and lots: HeartStart XL battery M3516A labeled with Made in Taiwan and an R-2011-12 Date of Manufacture

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0011-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0011-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-10	2012-10-04

Product code MKJ

K021453Class IIIHeartstream Xl Defibrillator/monitor, Model #M4735aPhilips Medical Systems / cleared 2002-07-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)