Z-1298-2014 Class I Terminated
FDA device recall Z-1298-2014 was initiated by Draeger Medical Systems, Inc. on February 7, 2014 and is designated Class I. Reason for recall: The battery capacity of the optional PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (Evita Infinity V500) did not last as long as expected. The recall status is terminated (terminated August 17, 2015). Affected quantity: 1544.
Recall Details
- Product Type
- Devices
- Report Date
- April 9, 2014
- Initiation Date
- February 7, 2014
- Termination Date
- August 17, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1544
Product Description
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.
Reason for Recall
The battery capacity of the optional PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (Evita Infinity V500) did not last as long as expected.
Distribution Pattern
Nationwide Distribution
Code Information
all lots