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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Affected units may have a defective component that is intended to protect the internal circuitry from high voltages during shock delivery. The defective component may also prevent delivery of shocks in AED mode."
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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