31

Jul

2013

Cl ll Spacelabs ARKON Anesthesia Workstation

defects, recall

0

Company: Del Mar Reynolds Medical, Ltd.
Date of Enforcement Report: 7/31/2013
Class lI:

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. Recall Number Z-1771-2013

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.

RECALLING FIRM/MANUFACTURER
Del Mar Reynolds Medical, Ltd., Hertford, GB on 6/7/2013. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
9 units (4 in the US and 5 outside US)

DISTRIBUTION
Nationally and Internationally

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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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