The Recall Desk
HighFDA (Devices)·Z-1298-2014·Announced 2014-04-09

Draeger PS500 Power Supply Unit Recalled Due to Reduced Battery Capacity

Draeger Medical Systems is recalling 1,544 PS500 Power Supply Units because the battery capacity did not last as long as expected.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a critical care medical device where a power failure could lead to harm, but the source text does not report any injuries or illnesses, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Draeger Medical Systems, Inc. is recalling 1,544 units of the PS500 Power Supply Unit. This device is an optional component used with the Infinity ACS Workstation Critical Care (Evita Infinity V500), Evita V500, and/or Babylog VN500 Ventilators. The units are used for ventilation during short-term transport of patients within a hospital.

The recall was initiated because the battery capacity of the PS500 Power Supply Unit did not last as long as expected. The source text does not report any specific injuries, illnesses, or deaths associated with this defect.

The recall covers all lots of the product, which was distributed nationwide. The source text does not provide specific instructions for consumers or healthcare facilities on how to proceed with the recall, such as returning the units or contacting the manufacturer.

The recalled product

Product
Draeger PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (Evita Infinity V500), Evita V500 and /or Babylog VN500 Ventilators, used for ventilation during short term transport of patients within a hospital.
Affected units
1,544

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • all lots

Distribution

Distributed nationwide across the United States.