Stryker Launches Voluntary Field Action for Specific Units of the LIFEPAK ® 15 Monitor/Defibrillator

The company is notifying certain LIFEPAK 15 customers of 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. A device in this condition has the potential to delay delivery of therapy, and this delay in therapy has the potential to result in serious injury or death.

https://www.fda.gov/Safety/Recalls/ucm630455.htm

Source: Food and Drug Administration - February 1, 2019 Category: Food Science Source Type: news

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