Recall Z-1460-2017— Del Mar Reynolds Medical, Ltd.
Class II · Terminated
Class II FDA medical device recall by Del Mar Reynolds Medical, Ltd., initiated 2017-02-08, terminated 2017-10-19. It names one FDA 510(k) clearance: K113051. 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.. 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..
- Recalling firm
- Del Mar Reynolds Medical, Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-02-08
- Terminated
- 2017-10-19
- Firm location
- Hertford, N/A, United Kingdom
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.