Device product
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.
Z-1771-2013
Product summary
- Event
- Event 65630
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9 units (4 in the US and 5 outside US)
- Official record key
device-enforcement:Z-1771-2013
Official wording
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.
Code information: ARKN-000001, ARKN-000005, ARKN-000010, ARKN-000015, ARKN-000016, ARKN-000017, ARKN-000018, ARKN-000020, ARKN-000021.
Distribution pattern: Worldwide Distribution - USA including South Carolina and internationally to Canada and Great Britian.
Derived failure modes
-
Device software or design
software defect