Z-0608-2020 Class II Terminated
FDA device recall Z-0608-2020 was initiated by Philips North America, LLC on October 3, 2019 and is designated Class II. 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 attem… The recall status is terminated (terminated April 19, 2023). Affected quantity: 24,738 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 11, 2019
- Initiation Date
- October 3, 2019
- Termination Date
- April 19, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24,738 units
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.
Distribution Pattern
US Nationwide
Code Information
All Units, Model number 861290