Z-1609-2011

Philips HeartStart MRx Defibrillator Monitor (M3535A/M3536A) with software (SW) versions F.01.00 or F.01.01...

Name: Z-1609-2011 Philips HeartStart MRx Defibrillator Monitor (M3535A/M3536A) with software (SW) versions F.01.00 or F.01.01...
Creator: Philips Healthcare Inc.
Published: 2011-02-07
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2011-02-07 / Terminated / root cause: software

FDA source

Philips Healthcare Inc. began a recall of Philips HeartStart MRx Defibrillator Monitor (M3535A/M3536A) with software (SW) versions F.01.00 or F.01.01 and with all of the following hardware options... on 2011-02-07. The reason FDA records is "Software: EtCO2 and Ventilation Rate values may be labeled incorrectly". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1609-2011
Status: Terminated
Initiated: 2011-02-07
Posted: 2011-03-08
Terminated: 2017-03-16
Recalling firm: Philips North America LLC
Product: Philips HeartStart MRx Defibrillator Monitor (M3535A/M3536A) with software (SW) versions F.01.00 or F.01.01 and with all of the following hardware options EtCO2, IP and Temp. Used for the termination of ventricular tachycardia and ventricular fibrillation.
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: Software: EtCO2 and Ventilation Rate values may be labeled incorrectly.
Root cause tag: software
FDA root cause: Software design
Action: Philips Healthcare representatives issued an Urgent Medical Device letter on 2/7/11. Customers are asked to follow the Action to be taken by Customer/User section of the Urgent Medical Device Correction Notification. In this section, customers are given the following instructions: Philips software (SW) version F.01.03 (for M3535A and M3536A) and R.01.00 (for M3536A, English only) corrects this problem. If you have affected product a Philips Service Engineer will contact you to install software version F.01.03 or R.01.00. Until your software is updated your HeartStart MRx monitor/defibrillator can remain in service. If you are using the device in one of the use modes listed under problem description, make sure that operators are aware that even though the EtCO2 and ventilation rate values can display interchangeably (unexpectedly or randomly switch) under either the ventilation rate label or the EtCO2 label, the values themselves can be identified by their color (for example if the ventilation rate label is white, the ventilation value is displayed as white). Customers are to contact their local Philips representative at 1-800-722-9377, if they need further information or support regarding this issue.
Quantity in commerce: 2382 units
Distribution: Worldwide -- USA, Canada, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRAZIL, CHINA, COLOMBIA, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, FRANCE, GERMANY, HONG KONG, INDIA, IRELAND, ISRAEL, ITALY, KENYA, LATVIA, MALAYSIA, MEXICO, NEW ZEALAND, NORWAY, PHILIPPINES, REUNION, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWITZERLAND, THAILAND, UNITED ARAB EMIRATES, and UNITED KINGDOM.
Product codes and lots: Software versions: F.01.00 or F.01.01

Product code MKJ

K051134Class IIIHeartstart Mrx with Q-CPR Option, Models M3535a or M3536aPhilips Medical Systems / cleared 2005-09-08

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)