Philips HeartStart MRx Monitor/Defibrillator Recalled for Hardware Defects
Philips is recalling HeartStart MRx Monitor/Defibrillators because the CO2 inlet port can become inaccessible or the handle can separate from the housing.
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 (defibrillator) where a defect (handle separation or inaccessible port) could prevent the device from functioning correctly during a life-threatening emergency, representing a risk of harm even without reported injuries.
Plain-English summary
Philips Medical Systems, Inc. is recalling 27,918 units of the HeartStart MRx Monitor/Defibrillator (Models M3535A, M3536A, M3536M, M3536MC, M3536M4, and M3536M5). The devices are used by qualified medical personnel to terminate ventricular tachycardia and ventricular fibrillation. The recall covers units distributed nationwide in the US and internationally to numerous countries.
The recall is due to two potential hardware issues. First, the CO2 Inlet Port associated with end-tidal carbon dioxide (EtCO2) monitoring can be pushed into the MRx housing, making it inaccessible. Second, the handle can separate from the MRx housing due to breakage of mounts on the rear case. Only devices with the EtCO2 option or an old cap plate are affected; devices with a paddle tray or the new cap plate are not affected.
Qualified medical personnel should check their devices for the specific conditions described in the recall notice. Devices with the EtCO2 option or an old cap plate within the identified serial number ranges are affected. Users should follow the instructions provided by Philips for the Medical Device Correction.
The recalled product
- Product
- Philips HeartStart MRx Monitor/Defibrillator Models:M3535A, M3536A, M3536M, M3536MC, M3536M4, M3536M5 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 o
- Manufacturer
- Philips Medical Systems, Inc.
- Category
- Medical Device — Defibrillator
- Affected units
- 27,918
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 (9)
- Model M3535A: US00100100 to US00552845
- Model M3536A: US00100902 to US00552848
- Model M3536M: US00500002 to US00501201
- Model M3536MC: US00500001 to US00500087
- Model M3536M4: US00500003
- US00500004
- US00552673
- US00552678
- US00552679
Distribution
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