RegWardenFDA facility compliance records
Recall

Class I — Draeger Medical Systems, Inc.

Recalling firmDraeger Medical Systems, Inc.
Registered facilityView this company's 2 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass I
StatusTerminated
ReasonThe 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.
ProductDraeger 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.
Quantity1544
DistributionNationwide Distribution
Initiated2014-02-07
Classified2014-03-28
Terminated2015-08-17
Recall numberZ-1298-2014
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class I recall — Draeger Medical Systems, Inc. (Z-1298-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/67502/

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