Recall Z-0072-2018 ยท BSZ Gas-Machine, Anesthesia
Spacelabs Healthcare, Ltd.
Arkon Anesthesia Delivery System, Model 99999, and software version 2.61 and upgrade kit 050-9043-00 Rev G. The Spacelabs Arkon Anesthesia Workstation is intended for use in the hospital environment and operating room. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and
| Date | Nov 21, 2017 (initiated Oct 11, 2017) |
| Status | Terminated |
| Reason | Arkon Anesthesia Workstation, with software version 2.61, experienced failure in mechanical ventilation, oxygen and anesthetic gas delivery, with concurrent failure of the display unit that resulted in a blank screen without audible or visible alarms. |
| Root cause | Software design |
| Action | Spacelabs Healthcare sent an Urgent Medical Device Correction letter dated October 24, 2017. The letter identified the affected product problem and actions to be taken. For questions call 1-800-522-7025 and select 4 for Technical Support. |
| Quantity | 110 units |
| Distribution | Nationwide Distribution to the states of NM, WY, FL, NC, MS, CO, CT, ME, and AL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113051 | SPACELABS ARKON ANESTHESIA WORKSTATION Spacelabs Healthcare, Mar 22, 2012 |