Philips HeartStart MRx Defibrillators Recalled for Defective Component
Philips is recalling 71 HeartStart MRx defibrillators because a defective component may prevent shock delivery in AED mode.
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 high-risk medical device where a defect may prevent the delivery of life-saving shocks, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Philips North America, LLC is recalling 71 units of the HeartStart MRx Defibrillator (Models M3535A and M3536A). The recall is due to a defective component intended to protect internal circuitry from high voltages during shock delivery.
This defect may also prevent the delivery of shocks in AED mode. The affected units were distributed internationally to India, Ireland, Japan, Republic of Korea, Malaysia, Mexico, South Africa, and the United Kingdom. There is no U.S. distribution for these specific units.
Qualified medical personnel using these devices should contact Philips for instructions on how to address the defect. The device is intended for use by trained medical personnel for the termination of ventricular tachycardia and ventricular fibrillation.
The recalled product
- Product
- MRx Defibrillator Model # M3535A & M3536A, UDI 00884838000018(21)US00601969 Product Usage: 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
- Manufacturer
- Philips North America, LLC
- Category
- Medical Device — Defibrillator
- Affected units
- 71
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 (20)
- Serial Numbers: US00601802
- US00601968
- US00601969
- US00602114
- US00602122
- US00602124
- US00602125
- US00602126
- US00602127
- US00602128
- US00602145
- US00602180
- US00602182
- US00602184
- US00602185
- US00602186
- US00602187
- US00602189
- US00602206
- US00602236
Distribution
Distribution scope not specified by the agency.
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