HeartStart XL+ Defibrillator/Monitor, Model 861290
Reported: December 11, 2019 Initiated: October 3, 2019 #Z-0608-2020
Product Description
HeartStart XL+ Defibrillator/Monitor, Model 861290
Reason for Recall
Device may fail to turn on or unexpectedly attempt to restart, rendering it unable to return to a ready for use state. Additionally, this issue may occur when the device is in standby mode, when attempting to power on to run a self-test. If this occurs, the device will indicate that it is not ready for use.
Details
- Recalling Firm
- Philips North America, LLC
- Units Affected
- 24,738 units
- Distribution
- US Nationwide
- Location
- Andover, MA
Frequently Asked Questions
What product was recalled? ▼
HeartStart XL+ Defibrillator/Monitor, Model 861290. Recalled by Philips North America, LLC. Units affected: 24,738 units.
Why was this product recalled? ▼
Device may fail to turn on or unexpectedly attempt to restart, rendering it unable to return to a ready for use state. Additionally, this issue may occur when the device is in standby mode, when attempting to power on to run a self-test. If this occurs, the device will indicate that it is not ready for use.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 11, 2019. Severity: Moderate. Recall number: Z-0608-2020.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11