—#125492

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

FDA product code: MKJ — Automated External Defibrillators (Non-Wearable)
Device class: Class 3
Medical specialty: Cardiovascular
510(k) numbers: K051134
Affected lot / code info: MRx units with the Q-CPR Meter option B08 and with a serial number within the range: US00100253 and US00571587

Why it was recalled

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 (FDA determination)

Software Design Change

Action the firm took

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.

Recalling firm

Firm: Philips Medical Systems, Inc.
Address: 3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2014-02-18
Posted by FDA: 2014-03-12
Terminated: 2020-09-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #125492. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.