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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
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…
- Manufacturer
- Philips Medical Systems, Inc.
- Hazard
- Affected units
- 93
Distribution
Related recalls
Same manufacturer · Philips Medical Systems, Inc.
See all →- ModeratePhilips Medical Systems Recalls Foot Switches for Bent Pedal Defect
FDA (Devices) · 2016-04-06
- ModeratePhilips MultiDiagnost Eleva Foot Switches Recalled for Bent Pedal Defect
FDA (Devices) · 2016-04-06
- SeverePhilips IntelliVue Information Center iX Software Recall for Alarm Failure
FDA (Devices) · 2015-12-16
- HighPhilips INTEGRIS Cardio System Ceiling Suspension Recall
FDA (Devices) · 2015-12-09
- SeverePhilips INTEGRIS Vascular System Recall for Ceiling Suspension Fall Risk
FDA (Devices) · 2015-12-09
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
Similar recalls
- SeverePhilips HeartStart MRx Monitor/Defibrillator Recalled for Therapy Failure Risk
FDA (Devices) · 2013-05-08
- SeverePhilips HeartStart MRx Monitor/Defibrillator Recalled for Incorrect Therapy Risk
FDA (Devices) · 2013-07-31
- SeverePhilips HeartStart MRx Monitor/Defibrillator Recalled for Charging Failure
FDA (Devices) · 2018-06-06
- HighPhilips HeartStart MRx Monitor/Defibrillators Recalled for Missing Field Action Corrections
FDA (Devices) · 2020-06-03
- SeverePhilips HeartStart MRx Monitor/Defibrillator Recall for Charging Failure
FDA (Devices) · 2016-05-11
- SeverePhilips HeartStart MRx Monitor/Defibrillator Recalled for Malfunction Risk
FDA (Devices) · 2015-01-21