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Terminated

SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed. This system includes a ventilator.

FDA Recall Z-1442-2014 · Posted 2014-04-12

Recalling FirmDel Mar Reynolds Medical, Ltd.
Recall StatusTerminated
Product CodeCBK
Date Initiated2014-03-10
Date Terminated2014-08-20
Product Quantity16 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.

Firm Action

Spacelabs Healthcare sent an Urgent Medical Device Correction letter, dated 11 March 2014, to consignees. The letter identified the product, the problem, and the actions to be taken by the customer. The letter stated that Spacelabs Field Service personnel will be contacting consignees to schedule a convenient time to install, at no cost, a software upgrade. Consignees with questions about this corrective action program, please contact Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical Support.

Root Cause

Software in the Use Environment

Distribution Pattern

USA Nationwide Distribution in the states of North Carolina and South Carolina

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K113051SPACELABS ARKON ANESTHESIA WORKSTATIONSpacelabs Healthcare · 2012-03-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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