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U.S. Department of Health and Human Services

Enforcement Report - Week of July 31, 2013

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Product Detail

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.
Recall Number Z-1771-2013
Classification Class II
Code Info ARKN-000001, ARKN-000005, ARKN-000010, ARKN-000015, ARKN-000016, ARKN-000017, ARKN-000018, ARKN-000020, ARKN-000021.
Product Distributed Qty 9 units (4 in the US and 5 outside US)
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.

Event Detail

Event Id 65630
Product Type Devices
Status Ongoing
Recalling Firm Del Mar Reynolds Medical, Ltd.
City Hertford
State
Country GB
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-06-07
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - USA including South Carolina and internationally to Canada and Great Britian.
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