sábado, 2 de febrero de 2019

Recalls, Market Withdrawals, & Safety Alerts > Stryker Launches Voluntary Field Action for Specific Units of the LIFEPAK® 15 Monitor/Defibrillator

Recalls, Market Withdrawals, & Safety Alerts > Stryker Launches Voluntary Field Action for Specific Units of the LIFEPAK® 15 Monitor/Defibrillator









Stryker announced today that the company is launching a voluntary field action on specific units of the LIFEPAK 15 Monitor/Defibrillators.
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.
The company is contacting customers with impacted devices to schedule the correction of their device(s), which will include an update to the firmware for a component on the System Printed Circuit Board Assembly.

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