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Del Mar Reynolds Medical, Ltd. recalls Arkon Anesthesia Delivery System, Model 99999. Product Usage: Continuous Ventilator The Arkon Anesthesia Delivery S
Recalled March 22, 2017 · FDA recall Z-1460-2017 · Del Mar Reynolds Medical
Hazard
Spacelabs has received reports of the Arkon Anesthesia Delivery System, Model 99999, shutting down without warning. The power supply has failed in a way that does not trigger the normal on battery alarms. · FDA Class II
Units
325 devices sold to 35 US consignees and 76 devices sold to 14 international consignees
Sold at
Worldwide Distribution - US nationwide and internationally in the following countries: BOLIVIA, CANADA, CHINA, ECUADOR, FRANCE, IRELAND, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, PANAMA, PERU, POLAND, UNITED KINGDOM.
Description
Spacelabs has received reports of the Arkon Anesthesia Delivery System, Model 99999, shutting down without warning. The power supply has failed in a way that does not trigger the normal on battery alarms.
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 use Emergency O2 and manually ventilate the patient, providing gas and agent. However, the anesthesiologist will not have access to mechanical ventilation or ventilator monitoring.
Manufacturer(s)
Del Mar Reynolds Medical, Ltd.
Made in
United Kingdom
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →