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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "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."
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.
- Manufacturer
- Draeger Medical Systems, Inc.
- Hazard
- 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.
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