Draeger PS500 Power Supply Unit of the Infinity ACS… recallZ-1298-2014 · Draeger Medical Systems, Inc. · initiated Feb 7, 2014
Class I Terminated All recalls posted in March 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Draeger Medical Systems, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Component design/selection
What the company is doing
Drager sent an Urgent Medical Device Recall letter dated February 2014. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to use an affected device for patient transport only if absolutely necessary; not to rely on the battery charge status indicator, always supervise the patient and the ventilator during transport; ensure that they have a manual breathing bag available for manual ventilation as recommended in the instructions for use. If the power fail alarm occurs during transport, immediately provide manual ventilation and connect ventilator to a wall power source to resume ventilation. DragerService representative will schedule the implementation of a permanent solution as quickly as possible. The letter should be distributed to users of the Evita V500 and /or Babylog VN500 Ventilators to make them aware of this device behavior and risk mitigation measures. Customers with questions were instructed to call 1-800-543-5047. For questions regarding the operation and/or servicing of their Draer ventilator contact Technical Support at 1-800-543-5047. For questions regarding this recall call 215-721-5400.
Recall details
- Recall number
- Z-1298-2014
- Recall class
- Class I (most serious)
- Status
- Terminated
- Initiated by the company
- Feb 7, 2014
- Posted by the FDA
- Mar 28, 2014
- Recalling firm
- Draeger Medical Systems, Inc.
- Quantity
- 1544
- Product code
- CBK
- FDA submissions
- K093632, K093633
- Distribution
- Nationwide Distribution
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.
Code information (models, lots, serial numbers)
all lots
Other devices under the same FDA submission
2 devices cleared under K093632, K093633 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- IACS Workstation Critical Care 8416400Drägerwerk AG & Co. KGaA · Ventilator, Continuous, Facility Use1 recall5 deaths213 reports
- IACS Workstation Neonatal Care 8417400Drägerwerk AG & Co. KGaA · Ventilator, Continuous, Facility Use1 recall66 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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