Recall Z-2093-2017 ยท BSZ Gas-Machine, Anesthesia
Del Mar Reynolds Medical, Ltd.
Spacelabs Healthcare Arkon Anesthesia Delivery System is intended for use in the hospital environment and operating room. Absorber Adapter Assembly Service Kit, part number: 050-9045-00. Absorber Adapter Assembly, part number: 650-1648-01. Arkon Absorber Canister Carrier, part number: 380-0916-01.
| Date | Apr 14, 2017 |
| Status | Terminated |
| Reason | Reports of the Canister Carrier breaking during absorbent exchange or during anesthesia machine transit, causing a leak in the breathing circuit, which could cause hypoventilation in the patient. |
| Root cause | Device Design |
| Action | Spacelabs sent an URGENT - MEDICAL DEVICE CORRECTION letter dated April 13, 2017, to US customers via priority service. The customer letter (translated as necessary) will be emailed to all international subsidiaries and distributors of record on April 14, 2017. The letter announced that the The Arkon Anesthesia Delivery System, Model 99999, and the Absorber Adapter Assembly Kit part number 050-9045-00, and Absorber Adapter Assembly part number 650-1648-01 are being recalled. Customers are advised that The Arkon Anesthesia Delivery Systems Model 99999 with Absorber Adapter Assembly part numb |
| Quantity | 62 total (US= 19 devices and 32 kits; International = 11 devices) |
| Distribution | US distribution in FL, LA, MS, NC, NC, SC and WY and Internationally to Panama and 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 |