Recall Z-1771-2013 ยท CBK Ventilator, Continuous, Facility Use
Del Mar Reynolds Medical, Ltd.
Spacelabs ARKON Anesthesia Workstation. Spacelabs ARKON Anesthesia Workstation 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 may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer.
| Date | Jul 19, 2013 (initiated Jun 7, 2013) |
| Status | Terminated |
| Reason | Spacelabs ARKON Anesthesia System is recalled due to software defect. The System Status Computer may incorrectly determine that a communication error has occurred. If this situation occurs, a buzzer will activate and a yellow triangle will be displayed on the System Status Computer screen that alerts the user of this error. |
| Root cause | Software design |
| Action | Spacelabs Healthcare sent an Urgent Medical Device Correction" letter, dated June 20, 2013, to all affected consignees. The letter identified the product, th problem, and the action to be taken by the consignee. Consignees were instructed to advise their staff of the situation. Consignees were also advised that Spacelabs Field Service personnel would be contacting them at their facility to schedule installation of a software update to resolve the issue at not cost to the consignee. Consignees with questions were instructed to call Technical Support at 1-800-522-7025 and select option 2. Fo |
| Quantity | 9 units (4 in the US and 5 outside US) |
| Distribution | Worldwide Distribution - USA including South Carolina and internationally to Canada and Great Britian. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113051 | SPACELABS ARKON ANESTHESIA WORKSTATION Spacelabs Healthcare, Mar 22, 2012 |