LIFEPAK 15 Monitor/Defibrillator
Date of Recall: February 1, 2019
Recalling Firm(s): Stryker
Product: LIFEPAK 15 Monitor/Defibrillator
Scope of recall: Specific Units. You can find out of your unit is part of the recall by going to the website below and filling in your Account Number:
Description: Stryker has voluntarily recalled specific units of the LIFEPAK 15 Monitor/Defibrillator due to an issue that may cause the device to lock-up after a defibrillation shock is delivered. The lock-up condition is defined as a blank monitor display with LED lights on, indicating power to the device, but no response in the keypad and device functions. This has the potential to cause a delay delivery of therapy and this delay has the potential to cause serious injury or death. Stryker has become aware of 58 complaints reported globally for this issue, including 6 events which the patient died following a delay in therapy. There are 13,003 devices potentially impacted by this issue and within the scope of this recall.
For more information, please see the safety announcement posted on the FDA website. https://www.fda.gov/Safety/Recalls/ucm630455.htm.