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

FDA device recall Z-1194-2014 · posted 2014-03-12 · Terminated

Recall details

Recalling firm

Philips Medical Systems, Inc.

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.

Action taken

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.

Root cause

Software Design Change

Status

Terminated

Product code

MKJ

Quantity affected

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 KOR

Date initiated

2014-02-18

Date posted

2014-03-12

Date terminated

2020-09-17

Location

Andover, MA

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