Recall Z-1442-2014 ยท CBK Ventilator, Continuous, Facility Use
Del Mar Reynolds Medical, Ltd.
SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed. This system includes a ventilator.
| Date | Apr 12, 2014 (initiated Mar 10, 2014) |
| Status | Terminated |
| Reason | The System may go into a controlled failed state if a series of parameters on the user interface are activated in a specific sequence. |
| Root cause | Software in the Use Environment |
| Action | Spacelabs Healthcare sent an Urgent Medical Device Correction letter, dated 11 March 2014, to consignees. The letter identified the product, the problem, and the actions to be taken by the customer. The letter stated that Spacelabs Field Service personnel will be contacting consignees to schedule a convenient time to install, at no cost, a software upgrade. Consignees with questions about this corrective action program, please contact Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical Support. |
| Quantity | 16 units distributed in the US |
| Distribution | USA Nationwide Distribution in the states of North Carolina and South Carolina |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113051 | SPACELABS ARKON ANESTHESIA WORKSTATION Spacelabs Healthcare, Mar 22, 2012 |