Arkon Anesthesia Delivery System Recalled for Unannounced Power Supply Failure
Del Mar Reynolds Medical is recalling Arkon Anesthesia Delivery Systems because the power supply can fail without triggering normal battery alarms.
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: The recall is classified as FDA Class II. The hazard involves a critical life-support device failing silently, which poses a significant risk of harm to patients if emergency ventilation or oxygen delivery is interrupted without warning.
Plain-English summary
Del Mar Reynolds Medical, Ltd. is recalling the Arkon Anesthesia Delivery System, Model 99999, following reports that the device shuts down without warning. The issue involves a power supply failure that does not trigger the standard "on battery" alarms, potentially leaving clinicians unaware that the device has lost power.
The recall affects 325 devices sold to 35 US consignees and 76 devices sold to 14 international consignees. Distribution was worldwide, including the United States, Bolivia, Canada, China, Ecuador, France, Ireland, Malaysia, Mexico, Morocco, Netherlands, Panama, Peru, Poland, and the United Kingdom. Specific serial numbers for affected units are listed in the official recall notice.
This is an FDA Class II recall. The Arkon system is designed to provide emergency oxygen, vaporized agent delivery, and manual ventilation during power failures. A silent power failure could compromise the ability to provide these critical functions. Users should check their device serial numbers against the recall list and contact the manufacturer for instructions.
The recalled product
- Product
- Arkon Anesthesia Delivery System, Model 99999. Product Usage: Continuous Ventilator The Arkon Anesthesia Delivery System is designed to provide emergency oxygen, vaporized agent delivery and manual ventilation in the event of a power failure scenario. Clinicians are able to
- 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 (20)
- US Serial numbers: ARKN-000003
- ARKN-000004
- ARKN-000011
- ARKN-000012
- ARKN-000013
- ARKN-000014
- ARKN-000016
- ARKN-000017
- ARKN-000019
- ARKN-000020
- ARKN-000021
- ARKN-000022
- ARKN-000023
- ARKN-000024
- ARKN-000025
- ARKN-000026
- ARKN-000027
- ARKN-000028
- ARKN-000029
- ARKN-000030
Distribution
Distributed nationwide across the United States.
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