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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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:
Related recalls
Same manufacturer · Del Mar Reynolds Medical, Ltd.
See all →- HighSpacelabs Arkon Anesthesia Delivery System Canister Carrier Recall
FDA (Devices) · 2017-05-24
- SevereArkon Anesthesia Delivery System Recalled for Unannounced Power Supply Failure
FDA (Devices) · 2017-03-22
- HighSpacelabs Pediatric Flow Sensor Kit Recalled for Inaccurate Low Flow Readings
FDA (Devices) · 2015-04-29
- SevereSpaceLabs Arkon Anesthesia Delivery System Recalled for Software Failure
FDA (Devices) · 2014-04-23
- SevereSpacelabs recalls anesthesia workstation absorbers due to potential switch failure
FDA (Devices) · 2013-11-27
Same hazard · software defect
See all →- HighPhilips Spectral CT Systems Recalled for Software Issues Affecting Safety
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
- ModerateUnited Imaging uMI 550 PET/CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
- ModeratePhilips SmartPath to MR 7700 Recalled for Incorrect DTI Export Data
FDA (Devices) · 2026-10-07
Similar recalls
- SevereSpaceLabs Arkon Anesthesia Delivery System Recalled for Software Failure
FDA (Devices) · 2014-04-23
- SevereSpacelabs Arkon Anesthesia Workstation Recalled for Mechanical and Display Failures
FDA (Devices) · 2017-11-29
- SevereSpacelabs Arkon Anesthesia Delivery System Recalled for Ventilation Failure Risk
FDA (Devices) · 2018-08-22
- SevereArkon Anesthesia Delivery System Recalled for Unannounced Power Supply Failure
FDA (Devices) · 2017-03-22
- SevereSpacelabs Anesthesia Workstation Recall for Carbon Dioxide Defect
FDA (Devices) · 2013-03-27
- HighSpacelabs Arkon Anesthesia Delivery System Canister Carrier Recall
FDA (Devices) · 2017-05-24