Philips HeartStart MRx Monitor/Defibrillator Recall for Labeling Error
Philips is recalling 93 HeartStart MRx Monitor/Defibrillators because the first therapy energy setting is mislabeled as 10 instead of 1-10.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error that could lead to incorrect therapy settings, but no injuries or illnesses are reported in the source text.
Plain-English summary
Philips Medical Systems, Inc. is recalling 93 units of the HeartStart MRx Monitor/Defibrillator (Models M3536A Options A20 - A27, HeartStart MRx ALS Monitor (Grey)). The recall is due to an error in the printing of the therapy energy setting labels. Specifically, the first energy setting is labeled '10' when it should be labeled '1-10'.
The affected devices were distributed worldwide, including in the United States (Indiana, Mississippi, Texas, and Virginia) and in Denmark, France, Germany, Spain, and Switzerland. The device is intended for use by qualified medical personnel trained in basic life support, advanced cardiac support, or defibrillation, and must be used by or on the order of a physician.
Qualified medical personnel should stop using the affected devices and contact Philips Medical Systems for instructions on how to correct the labeling error. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Philips HeartStart MRx Monitor/Defibrillator Models: M3536A Options A20 - A27, HeartStart MRx ALS Monitor (Grey) The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel tr
- Manufacturer
- Philips Medical Systems, Inc.
- Hazard
- Affected units
- 93
Distribution
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