Draeger Perseus A500 Anesthesia Workstation Recalled for Power Switch Failure
Draeger Medical is recalling 34 Perseus A500 Anesthesia Workstations because the main power switch may fail during use, causing ventilation or fresh gas delivery failures.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The recall is classified as FDA Class I, which per the rubric mandates a severity score of 5 (Critical) regardless of other factors, as it indicates a reasonable probability of serious adverse health consequences or death.
Plain-English summary
Draeger Medical, Inc. is recalling 34 units of the Perseus A500 Anesthesia Workstation (Model MK06000). The device is intended for anesthetizing adults, children, and neonates and supports various ventilation modes. The recall is due to a potential problem with the device's main power switch, which may spontaneously fail during use.
If the power switch fails, the workstation may experience a fresh gas delivery failure and a ventilator failure with respective alarms, or it may shut down completely with an audible alarm. The affected units were distributed in the United States to the states of Wisconsin, Pennsylvania, Ohio, Maine, Illinois, and New York.
The recall is classified as FDA Class I, which indicates a reasonable probability that the use of or exposure to the violative product will cause serious adverse health consequences or death. Users should contact Draeger Medical for instructions on how to address the defect.
The recalled product
- Product
- Perseus A500 Anesthesia Workstation, MK06000. Intended for use in anesthetizing adults, children, and neonates and can be used for automatic and manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing.
- Manufacturer
- Draeger Medical, Inc.
- Affected units
- 34
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)
- and ASHK-0087.
Distribution
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