Philips HeartStart MRx Monitor/Defibrillator Recalled for Shock Delivery Failure
Philips is recalling HeartStart MRx Monitor/Defibrillators because they may display a Red X during automated tests, indicating a failure that could prevent the delivery of a shock or pacing.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (defibrillator) where the defect may prevent the delivery of a shock and pacing, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Philips Medical Systems, Inc. is recalling 3,541 units of the Philips HeartStart MRx Monitor/Defibrillator. The affected model numbers are M3535A, M3536A, M3536M, M3536M4, M3536M6, 861288, 861289, 861464, 861483, and 861491. The units have serial numbers within the range of US00100204 to US00570921.
The recall is due to a defect where the device may display a Red X in the Ready For Use (RFU) indicator during automated tests. This indicator informs the user that a failure has been detected that may prevent the delivery of a shock and pacing.
The affected devices were distributed nationwide and in numerous foreign countries, including 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, and Viet Nam. Users should contact Philips Medical Systems for further instructions regarding the recall.
The recalled product
- Product
- Philips HeartStart MRx Monitor/Defibrillator Model numbers: M3535A, M3536A, M3536M,M3536M4,M3536M6,861288,861289,861464,861483,and 861491
- Manufacturer
- Philips Medical Systems, Inc.
- Affected units
- 3,541
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial numbers within the range: US00100204 to US00570921
Distribution
Distributed nationwide across the United States.
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