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U.S. Department of Health and Human Services

Enforcement Report - Week of April 23, 2014

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Product Detail

Product Description SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed. This system includes a ventilator.
Recall Number Z-1442-2014
Classification Class I
Code Info SERIAL NUMBERS OF UNITS DISTRIBUTED IN THE US: ARKN-000011, ARKN-000016, ARKN-000017, ARKN-000019, ARKN-000020, ARKN-000021, ARKN-000022, ARKN-000023, ARKN-000024, ARKN-000025, ARKN-000026, ARKN-000027, ARKN-000028, ARKN-000029, ARKN-000030, and ARKN-000031.
Product Distributed Qty 16 units distributed in the US
Reason For Recall The System may go into a controlled failed state if a series of parameters on the user interface are activated in a specific sequence.

Event Detail

Event Id 67781
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 2014-03-10
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern USA Nationwide Distribution in the states of North Carolina and South Carolina
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