Z-1771-2013 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 31, 2013
- Initiation Date
- June 7, 2013
- Termination Date
- August 29, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9 units (4 in the US and 5 outside US)
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Worldwide Distribution - USA including South Carolina and internationally to Canada and Great Britian.
Code Information
ARKN-000001, ARKN-000005, ARKN-000010, ARKN-000015, ARKN-000016, ARKN-000017, ARKN-000018, ARKN-000020, ARKN-000021.