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Mc Kesson Anesthesia-Rx Model Number 8.0.2 & 8.0.1 with RapiDispense Product Usage: Automated anesthesia cart that monit

FDA device recall Z-2089-2013 · posted 2013-08-26 · Terminated

Recall details

Recalling firm
MCKESSON TECHNOLOGIES INC
Reason for recall
The firm issued a clinical alert after users reported an issue where the Anesthesia-Rx system was interrupted ANF became temporarily unavailable during use.
Action taken
McKesson sent a Clinical Alert letter dated July 22, 2013 to all affected customers. The letter identified the affected product, symptoms, and actions to be taken. McKesson committed to releasing 8.0.2 Update 1.5 to affected customers which will include enhanced code to prevent the unhandled excpetion errors. Additional resolution steps were included in the letter. For questions call 1-800-700-8737.
Root cause
Software design
Status
Terminated
Product code
BRY
Quantity affected
106
Distribution
USA Nationwide Distribution in the states AR, MD, NJ, NY, PA, and WV.
Date initiated
2013-07-22
Date posted
2013-08-26
Date terminated
2014-06-19
Location
Alpharetta, GA

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