Medical Device Safety and Recalls: Dräger Evita V500 and Babylog VN500 Ventilators - Recall Expanded to Include Optional PS500 Batteries with New Power Supply Firmware

"U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx> · Thu, 03 Mar 2016 15:18:51 -0600

Title:     Medical Device Safety and Recalls: Dräger Evita V500 and Babylog VN500 Ventilators - Recall Expanded to Include Optional PS500 Batteries with New Power Supply Firmware

  Dräger Medical has expanded its December 2015 recall to include the PS500 Optional Power Supply units that were updated with new software as part of the December recall. The new software installed failed to correct the issue depleting the battery and Dräger Medical will now replace all affected PS500 power supply units.
The ongoing PS500 power supply issue could cause the ventilator to shut down unexpectedly. If the ventilator shuts down, a patient may not receive necessary oxygen. This could cause patient injury or death.

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