Spacelabs ARKON Anesthesia Workstation Recalled for Software Defect
Del Mar Reynolds Medical is recalling nine Spacelabs ARKON Anesthesia Workstations due to a software defect that may cause false communication error alerts.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The defect causes false alarms (buzzer and visual alert) rather than a direct failure of the device's primary function or a reported injury, fitting the criteria for a moderate severity issue.
Plain-English summary
Del Mar Reynolds Medical, Ltd. is recalling nine units of the Spacelabs ARKON Anesthesia Workstation. The recall involves four units in the United States and five units outside the US, with distribution in South Carolina, Canada, and Great Britain. The affected units are identified by specific serial codes including ARKN-000001, ARKN-000005, ARKN-000010, ARKN-000015, ARKN-000016, ARKN-000017, ARKN-000018, ARKN-000020, and ARKN-000021.
The recall is due to a software defect in the System Status Computer. The computer may incorrectly determine that a communication error has occurred. If this happens, a buzzer will activate and a yellow triangle will be displayed on the screen to alert the user of the error.
The source text does not specify instructions for consumers or healthcare providers on how to proceed with the recall or remediation.
The recalled product
- Product
- Spacelabs ARKON Anesthesia Workstation. Spacelabs ARKON Anesthesia Workstation may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the
- Manufacturer
- Del Mar Reynolds Medical, Ltd.
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 (9)
- ARKN-000001
- ARKN-000005
- ARKN-000010
- ARKN-000015
- ARKN-000016
- ARKN-000017
- ARKN-000018
- ARKN-000020
- ARKN-000021.
Distribution
Distributed in 1 state:
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