Z-1194-2014Class II

Philips HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A with Q-CPR Meter Option B08 The...

Name: Z-1194-2014 Philips HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A with Q-CPR Meter Option B08 The...
Creator: Philips Medical Systems, Inc.
Published: 2014-02-18
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2014-02-18 / Terminated / root cause: software

FDA source

Philips Medical Systems, Inc. began a recall of Philips HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A with Q-CPR Meter Option B08 The HeartStart MRx is for use for the termination of... on 2014-02-18. FDA classified it as Class II and gives the reason as "When the HeartStart MRx.is used with the Q-CPR Meter in defibrillation mode, the Q-CPR Meter may incorrectly display the Do Not Touch the Patient icon". 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-1194-2014
Classification: Class II
Status: Terminated
Initiated: 2014-02-18
Posted: 2014-03-12
Terminated: 2020-09-17
Recalling firm: Philips North America LLC
Product: Philips HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A with Q-CPR Meter Option B08 The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: When the HeartStart MRx.is used with the Q-CPR Meter in defibrillation mode, the Q-CPR Meter may incorrectly display the Do Not Touch the Patient icon.
Root cause tag: software
FDA root cause: Software Design Change
Action: The firm, Philips Healthcare, sent an "URGENT -Medical Device Correction/Field Safety Notice" letter dated February 2014 on February 18, 2014 to its domestic and foreign customers. The letter describes the product, problem and actions to be taken. The customers were instructed to follow the Action to be Taken by Customer/User section of the attached Field Safety Notice; to continue to use your HeartStart MRx without the Q-CPR Meter attached. If you choose to use the HeartStart MRx with the Q-CPR Meter attached and you observe that the Q CPR Meter is displaying the Do Not Touch the Patient icon at an unexpected time, follow the MRx Instructions for Use and remove the meter from the patient and continue CPR according to your organization's protocol. Philips plans to take to remedy the issue. Philips will provide a software upgrade free of charge. If you have questions regarding this notification or need any further information or support, please contact your local Philips representative or call at 1-800-722-9377.
Quantity in commerce: 6583 units
Distribution: Worldwide distribution: US (nationwide) and to countries of: ARUBA AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA ECUADOR EGYPT FINLAND FRANCE GERMANY HONG KONG INDIA INDONESIA IRELAND ISRAEL ITALY KENYA KOREA, REPUBLIC OF KUWAIT LATVIA LIBYAN ARAB JAMAHIRIYA MALAYSIA MEXICO MOROCCO NETHERLANDS NORWAY OMAN PAKISTAN PHILIPPINES POLAND QATAR RUSSIAN FEDERATION SAUDI ARABIA SINGAPORE SOUTH AFRICA SPAIN SWEDEN SWITZERLAND TAIWAN, PROVINCE OF CHINA THAILAND TURKEY UKRAINE UNITED ARAB EMIRATES and UNITED KINGDOM.
Product codes and lots: MRx units with the Q-CPR Meter option B08 and with a serial number within the range: US00100253 and US00571587

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1194-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1194-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-19	2014-03-12

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)