Dräger Perseus A500 Anesthesia Workstation Recalled for Unexpected Battery-Power Shutdowns
Draeger Medical is recalling approximately 16,841 Dräger Perseus A500 Anesthesia Workstations due to unexpected shutdown while operating on battery power. The devices have been distributed nationwide and internationally.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall for a medical device, which mandates a minimum severity score of 4 per the rubric. Unexpected shutdown of an anesthesia workstation during battery operation poses a direct risk to patient safety in the surgical environment.
Plain-English summary
Draeger Medical, Inc. is recalling the Dräger Perseus A500 Anesthesia Workstation due to a risk of unexpected shutdown while operating on battery power. Approximately 16,841 units have been distributed.
The anesthesia workstation is medical equipment used in operating rooms to deliver and monitor anesthesia during surgical procedures. The affected devices may unexpectedly shut down when operating on battery power, which could interrupt critical operations and pose a safety risk in clinical environments.
The recalled devices have been distributed nationwide throughout the United States and internationally to over 70 countries worldwide, including Canada, the United Kingdom, Germany, Australia, and Japan.
Healthcare facilities that possess this device should contact Draeger Medical, Inc. for information about device safety measures and available corrective actions.
The recalled product
- Product
- Dr¿ger Perseus A500 Anesthesia Workstation
- Manufacturer
- Draeger Medical, Inc.
- Hazard
- unexpected-shutdown
- battery-failure
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 (3)
- Material No. MX06000
- UDI-DI: 04048675253600
- All Serial No.
Distribution
Distributed nationwide across the United States.
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