Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed. Recalled by Del Mar Reynolds Medical, Ltd. Due to The System may go into a controlled failed...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Del Mar Reynolds Medical, Ltd. directly.
Affected Products
SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed. This system includes a ventilator.
Quantity: 16 units distributed in the US
Why Was This Recalled?
The System may go into a controlled failed state if a series of parameters on the user interface are activated in a specific sequence.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Del Mar Reynolds Medical, Ltd.
Del Mar Reynolds Medical, Ltd. has 8 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report