Philips HeartStart MRx Defibrillators Recalled for Wireless Data Transmission Defect
Philips is recalling 220 HeartStart MRx defibrillators because the Wireless Link upgrade may fail to transmit data in specific configurations.
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 failure to transmit data could impact patient care, but no injuries or illnesses have been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Philips Medical Systems, Inc. is recalling 220 units of the M3536A HeartStart MRx with Wireless Link Upgrade (861289). The recall is due to a defect where the Wireless Link may be unable to transmit data when configured for a specific data flow.
The affected devices are intended for use by qualified medical personnel to terminate ventricular tachycardia and ventricular fibrillation. The recall covers devices distributed worldwide, including in the United States and internationally to Australia, Norway, and Spain.
Healthcare facilities and users should identify affected devices by checking the specific serial codes listed in the recall notice. Users should contact Philips Medical Systems for instructions on how to resolve the issue.
The recalled product
- Product
- M3536A HeartStart MRx with Wireless Link Upgrade (861289) 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 of the device and qualified by tra
- Manufacturer
- Philips Medical Systems, Inc.
- Category
- Medical Device — Defibrillator
- Affected units
- 220
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)
- US00100253
- US00547494
- US00565643
- US00567331
- US00100950
- US00558361
- US00565651
- US00567332
- US00204282
- US00560173
- US00565652
- US00567333
- US00210992
- US00560174
- US00565653
- US00567334
- US00210993
- US00560175
- US00565655
- US00567335
Distribution
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