Reported Jul 31, 2013 · Terminated
Spacelabs ARKON Anesthesia Workstation. Spacelabs ARKON Anesthesia Workstation may be used for the delivery of oxygen,…
Del Mar Reynolds Medical, Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Del Mar Reynolds Medical, Ltd. · 1-2 Harforde Ct., Foxholes · Hertford, N/A · N/A
Is this the product you have?
- 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.
- Lot codes and dates
ARKN-000001ARKN-000005ARKN-000010ARKN-000015ARKN-000016ARKN-000017ARKN-000018ARKN-000020ARKN-000021
- Amount recalled
- 9 units (4 in the US and 5 outside US)
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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