Recall Z-2589-2018 ยท CBK Ventilator, Continuous, Facility Use
Spacelabs Healthcare, Ltd.
Arkon Anesthesia Delivery System with Arkon Software Version 2.70, Display Unit Assembly 650-1769-00 installed, and Model #: 99999. This system includes a ventilator. 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 ci
| Date | Aug 10, 2018 (initiated Jul 11, 2018) |
| Status | Terminated |
| Reason | Arkon Anesthesia Delivery System may go into a failed state (mechanical ventilation ceases) while the machine is in use or while idle. |
| Root cause | Nonconforming Material/Component |
| Action | The firm, Spacelabs Healthcare, sent "Field Corrective Action Display Unit Resets" letters dated 7/3/2018 and 7/9/2018 to its customers via priority service on 07/11/2018. The letters informed them to circulate this notification to all affected persons and to add copies to appropriate user manuals. The firm will contact customers to replace the display assembly.. Customers with questions are encouraged to call Technical Support at 1-425-363-5212. |
| Quantity | 328 |
| Distribution | Worldwide Distribution: U.S (nationwide) to states of.: LA, NE, CO, WY, MT, NM, IN, ME, NY, IL, MA, TX, PA, PR; and countries (OUS) of: PERU BOLIVIA, PANAMA, MALAYSIA, POLAND, IRELAND, MOROCCO, MEXICO, CANADA, UNITED KINGDOM, FRANCE, and CHINA, ECUADOR. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113051 | SPACELABS ARKON ANESTHESIA WORKSTATION Spacelabs Healthcare, Mar 22, 2012 |