FDA Medical Device Recalls (openFDA)
Philips Medical Systems, Inc.: Philips HeartStart MRx Monitor/Defibrillator Model numbers: M3535A, M3536A, M3536M,M3536M4,M3536M6,861288,861289,861464,861483,and 861491
- Recall number
- Z-1155-2014
- Recalling firm
- Philips Medical Systems, Inc.
- Product
- Philips HeartStart MRx Monitor/Defibrillator Model numbers: M3535A, M3536A, M3536M,M3536M4,M3536M6,861288,861289,861464,861483,and 861491
- Status
- Terminated
- Initiated
- 2014-02-18
- Posted
- 2014-03-07
- Terminated
- 2020-09-11
- Reason
- MRx may display a Red X in the Ready For Use (RFU) indicator during automated tests informing the user that a failure has been detected that may prevent the delivery of a shock and pacing
- Root cause
- Component design/selection
- Action
- Philips Healthcare issued and Urgent Medical Device Correction notification/Field Safety Notice on 02/18/14 to inform customers of the issue, Philips is asking customers to follow the Action to be Taken by Customer/User section of the Urgent Medical Device Correction notification/Field Safety Notice: You can continue to use your MRx prior to receiving the hardware upgrade, provided that if you observe that the MRx is displaying a Red X in the Ready For Use (RFU) indicator\during automated tests, a failure has been detected that may prevent the delivery of a shock or pacing due to this issue. If this is observed you should turn the Therapy Knob to Monitor. An INOP message describing the failure is displayed. If needed, run an Operational Check for further information. If the condition persists, take the device out of use and call for service. Identify a readily available backup defibrillator to use in the event the affected HeartStart MRx fails to deliver therapy. Philips will perform a hardware upgrade (replace therapy boards) free of charge to be installed by a Philips Field Service Engineer. Contact your local Philips representative or call us at 1-800-722-9377.
- Quantity
- 3541 units
- Distribution
- Nationwide Foreign: AUSTRIA BAHRAIN BELGIUM BRAZIL CANADA CHINA EGYPT ESTONIA FINLAND FRANCE GERMANY GHANA ICELAND INDIA INDONESIA IRELAND ISRAEL ITALY JAPAN JORDAN KENYA KOREA, REPUBLIC OF LATVIA LEBANON LIBYAN ARAB JAMAHIRIYA LITHUANIA MALAYSIA MEXICO MOZAMBIQUE MYANMAR (Burma) NETHERLANDS NETHERLANDS ANTILLES NEW CALEDONIA NEW ZEALAND NORWAY PAKISTAN PERU POLAND PORTUGAL QATAR RUSSIAN FEDERATION SAUDI ARABIA SINGAPORE SOUTH AFRICA SPAIN SWEDEN SWITZERLAND TAIWAN, PROVINCE OF CHINA THAILAND TURKMENISTAN UNITED ARAB EMIRATES UNITED KINGDOM VIET NAM
- Lot, serial or model codes
- Serial numbers within the range: US00100204 to US00570921
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MKJ
- Firm FEI
- 1218950
- Firm city
- Andover
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28