Z-1226-03

Model M4735A HeartStart XL Defibrillator//Monitor

Name: Z-1226-03 Model M4735A HeartStart XL Defibrillator//Monitor
Creator: Philips Medical Systems
Published: 2003-09-02
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2003-09-02 / Terminated / root cause: labeling and UDI

FDA source

Philips Medical Systems began a recall of Model M4735A HeartStart XL Defibrillator//Monitor on 2003-09-02. The reason FDA records is "Instructions For Use include addtional information on configuration for selecting Power on Lead". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1226-03
Status: Terminated
Initiated: 2003-09-02
Posted: 2003-09-11
Terminated: 2005-04-20
Recalling firm: Philips North America LLC
Product: Model M4735A HeartStart XL Defibrillator//Monitor
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: Instructions For Use include addtional information on configuration for selecting Power on Lead
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Philips Medical in conjunction with NNC (National Notification Center) notified users by letter on 9/2/03. Users are provided with Addendum to the HeartStart XL Instructions for Use (to be added to the Instruction for Use) and to familiarize with the configurable Power on Lead. Users are rquested to acknowledge receipt by returning the Business reply Card.
Quantity in commerce: 16,736 units
Distribution: NATIONWIDE Foreign: Canada, Argentina, Brazil, Chile, Costa Rica, Mexico, Paraguay, Peru, Venezuela, Austalia, China,Hong Kong, India, Japan, Malaysia, Manilla, New Zealand, Manila, Singapore,Taiwan,Thailand, Vietnam, ALgeria, Australia,France,Italy, Netherlands,Norway,Oman,Poland, Portugal,South Africa, Spain, Sri Lanka, Sweden, Switzerland, Tunisia, Turkey, UK
Product codes and lots: Units with software versions A.02.00 or greater

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)