Recall Z-1460-2017 ยท CBK Ventilator, Continuous, Facility Use
Del Mar Reynolds Medical, Ltd.
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 a
| Date | Feb 8, 2017 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | On 08 February 2017, a customer letter will be sent via priority service, return receipt requested, to all U.S. customers. Records of notification will be maintained to ensure complete notification. On 15 February 2017, a customer letter (translated as necessary) will be emailed to all international subsidiaries and distributors of record. Records of notification will be maintained to ensure complete notification. Upgrade is expected to be available in April 2017; all affected Arkon Anesthesia Delivery Systems will receive a software upgrade onsite. |
| Quantity | 325 devices sold to 35 US consignees and 76 devices sold to 14 international consignees |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113051 | SPACELABS ARKON ANESTHESIA WORKSTATION Spacelabs Healthcare, Mar 22, 2012 |