Philips HeartStart XL+ Defibrillator Recalled for Therapy Board Malfunction
Philips is recalling 19 HeartStart XL+ defibrillators because a therapy board component could malfunction, potentially affecting the device's ability to deliver therapy.
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 is classified as FDA Class II. The hazard involves a medical device potentially failing to deliver therapy, which is a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Philips Medical Systems, Inc. is recalling 19 units of the HeartStart XL+ Defibrillator/Monitor, Model number 861290. The recall is due to a potential malfunction in a component on the HeartStart XL+ Therapy Board. This malfunction could potentially affect the device's ability to deliver therapy.
The affected devices were distributed worldwide, including in the United States (specifically Indiana and Washington) and in China, France, Germany, Italy, Malaysia, Panama, Saudi Arabia, Turkey, and the United Kingdom. Specific serial numbers for the affected units are listed in the official recall documentation.
Consumers and healthcare facilities should stop using the affected devices and contact Philips Medical Systems for further instructions on repair or replacement. This recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290, automatic external defibrillator.
- Manufacturer
- Philips Medical Systems, Inc.
- Category
- Medical Device — Defibrillator
- Affected units
- 19
Distribution
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