Philips HeartStart XL+ Defibrillator Recall for Software Communication Failure
Philips is recalling HeartStart XL+ Defibrillators because a software failure may lock users out of clinical mode, potentially delaying 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 involves a high-risk medical device where a software failure could delay life-saving therapy, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips Medical Systems, Inc. is recalling 9,872 units of the HeartStart XL+ Defibrillator/Monitor (Model 861290) equipped with system software version B.00.00 or B.00.01. The recall covers units distributed worldwide, including the United States and 23 other countries.
The recall is due to a software communication failure that may lock the user out of clinical mode. This malfunction could potentially cause a delay in therapy for patients requiring defibrillation.
Healthcare facilities and users should check their device serial numbers against the provided code ranges to determine if their units are affected. Affected units should be taken out of service and replaced or repaired according to the instructions provided by Philips Medical Systems.
The recalled product
- Product
- Philips HeartStart XL+ Defibrillator/Monitor with system software version B.00.00 or B.00.01 installed Model: 861290, automatic external defibrillator.
- Manufacturer
- Philips Medical Systems, Inc.
- Category
- Medical Device — Defibrillator
- Affected units
- 9,872
Distribution
Distributed nationwide across the United States.
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