Philips Healthcare Inc.: HeartStart MRx Monitor/Defribillator; Product Codes: M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6. The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation.

Recall number

Z-1189-2013

Recalling firm

Philips Healthcare Inc.

Product

HeartStart MRx Monitor/Defribillator; Product Codes: M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6. The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation.

Status

Terminated

Initiated

2013-04-08

Posted

2013-04-29

Terminated

2017-01-10

Reason

Device may fail to deliver defibrillation therapy in either Manual Defib or AED mode.

Root cause

Software design

Action

The firm, Philips Healthcare, sent an "Field Safety Notice-URGENT - MEDICAL DEVICE RECALL" letter dated April 2013 to its customers. The letter describes the product, problem and actions to be taken. In addition, letter provides instructions for using the MRx prior to receiving the software upgrade and informs the customer that Philips is initiating a correction consisting of a software upgrade for all units affected. The customers were instructed to follow the "ACTION TO BE TAKEN BY CUSTOMER/USER" section of the Field Safety Notice; send a copy of the attached package including customer letter and Field Safety Notice to any customer to whom you have distributed one of the affected device; and provide your local Philips organization with the names and addresses of customers to whom you have sold affected devices, so that arrangements can be made to perform the software updates. Should you have any questions or concerns about this device correction, please contact your local Philips representative at 1-800-722-9377. Philips updated the Field Safety Notice dated May 2013 to users who have not had the software upgrade performed. It provided additional information in the "Problem Description" and "Action to Be Taken By Customer/User".

Quantity

64972

Distribution

Worldwide distribution: USA (nationwide) and countries of: Afghanistan, Albania, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia and Herzegowina, Brazil, Brunei Darussalam, Bulgaria, Canada, Cambodia, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic Of, Kuwait, Laos, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Macau, Macedonia, Malaysia, Malta, Mexico, Mongolia, Morocco, Namibia, Nepal, Netherlands (Antilles), New Caledonia, New Zealand, Nicaragua, Nigera, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Puerto, Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, SRI Lanka, Sweden, Switzerland, Taiwan (Province of China), Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Veit Nam, and Yemen.

Lot, serial or model codes

Serial numbers ranging from US00100100 to US00565942  Product Codes: M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6

510(k) numbers

["K051134"]

PMA numbers

not on file

Product code

MKJ

Firm FEI

1218950

Firm city

Andover

Firm state

MA

Firm country

not on file

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

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