Z-1128-2007

Philips Medical HeartStartXL Defibrillator/Monitor Model : M4735A

Name: Z-1128-2007 Philips Medical HeartStartXL Defibrillator/Monitor Model : M4735A
Creator: Philips Medical Systems
Published: 2007-06-11
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2007-06-11 / Terminated / root cause: manufacturing process

FDA source

Philips Medical Systems began a recall of Philips Medical HeartStartXL Defibrillator/Monitor Model : M4735A on 2007-06-11. The reason FDA records is "The ECG signal may become unusable to assess patient condition and need for therapy". 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-1128-2007
Status: Terminated
Initiated: 2007-06-11
Posted: 2007-08-07
Terminated: 2016-08-08
Recalling firm: Philips North America LLC
Product: Philips Medical HeartStartXL Defibrillator/Monitor Model : M4735A
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: The ECG signal may become unusable to assess patient condition and need for therapy.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Philips Medical contacted accounts by letter dated June 11, 2007. Users are advised to remove product from service, if possible. If not, a back up unit should be available to use. Service reps will contact accounts to replace units.
Quantity in commerce: 312 units
Distribution: Worldwide, including USA, Canada, Australia, Brazil, China, Czech Republic, France, Germany, Hong Kong, India, Ireland, Italy, Japan, Korea, Kuwait, Macau, Poland, Portugal, Romania, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, UK, and Venezuela.
Product codes and lots: Serial Numbers: US00453441 through US00453910

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)