Philips HeartStart XL+ Defibrillator Recalled for Software and Hardware Issues
Philips is recalling 13,168 HeartStart XL+ defibrillators worldwide due to software and hardware issues that can affect device function.
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 3/5 (High).
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 and involves a high-risk medical device where functional issues could lead to harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Philips Electronics North America Corporation is recalling 13,168 HeartStart XL+ Defibrillator/Monitor units. The recall is due to multiple software and hardware issues that can affect the function of the device.
The affected devices were distributed worldwide, including the United States (including Puerto Rico), Canada, and numerous other countries. The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support, or defibrillation.
Healthcare facilities should contact Philips for instructions on how to address the software and hardware issues. The recall number is Z-2328-2015.
The recalled product
- Product
- Philips HeartStart XL+ Defibrillator/Monitor Product Usage: The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support or…
- Manufacturer
- Philips Electronics North America Corporation
- Category
- Medical Device — Defibrillator
- Affected units
- 13,168
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 (4)
- Serial Numbers in the following ranges: USO1100100 to USD1101095
- US11201096 to USD1203968
- US11303969 to USD1309471
- US11409472 to US61414022
Distribution
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