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.
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. 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
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 · device malfunction
See all →- SevereMedtronic MiniMed Flex Insulin Pumps Recalled for Failed Verification Tests
FDA (Devices) · 2026-10-14
- ModerateWilson-Cook Recalls Hemospray Endoscopic Hemostat Due to Adherence Issues
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys CS2 Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys CS2 Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Et Control Software Recalled for Anesthetic Delivery Interruption
FDA (Devices) · 2026-09-23
Similar recalls
- HighPhilips HeartStart XL+ Defibrillator Recalled for Software and Hardware Issues
FDA (Devices) · 2015-08-12
- SeverePhilips HeartStart XL+ Defibrillator Recall Due to Switch Failure
FDA (Devices) · 2019-11-27
- HighPhilips HeartStart XL+ Defibrillator Recall for Software Communication Failure
FDA (Devices) · 2014-04-16
- HighPhilips HeartStart XL+ Defibrillators Recalled for Potential Lockout
FDA (Devices) · 2013-02-27
- HighPhilips HeartStart XL+ Defibrillator Recall for Power-On Failure
FDA (Devices) · 2019-12-11
- SeverePhilips HeartStart XL Defibrillators Recalled for Power Board Failure
FDA (Devices) · 2014-03-05