Recall Z-1442-2014— Del Mar Reynolds Medical, Ltd.

Name: FDA recall Z-1442-2014
Creator: U.S. Food and Drug Administration
Published: 2014-03-10

Class I · Terminated

Class I FDA medical device recall by Del Mar Reynolds Medical, Ltd., initiated 2014-03-10, terminated 2014-08-20. It names one FDA 510(k) clearance: K113051. Product: SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed. This system includes a ventilator.. Reason: The System may go into a controlled failed state if a series of parameters on the user interface are activated in a specific sequence..

Recalling firm: Del Mar Reynolds Medical, Ltd.
Classification: Class I
Status: Terminated
Initiated: 2014-03-10
Terminated: 2014-08-20
Firm location: Hertford, N/A, United Kingdom

510(k) clearances named in this recall

1 on FDA's record

K113051 — SPACELABS ARKON ANESTHESIA WORKSTATIONSpacelabs Healthcare·cleared 2012-03-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.