Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2089-2013Class II

Mc Kesson Anesthesia-Rx Model Number 8.0.2 & 8.0.1 with RapiDispense

Mckesson Technologies, Inc. / initiated 2013-07-22 / Terminated / root cause: software

MCKESSON TECHNOLOGIES INC began a recall of Mc Kesson Anesthesia-Rx Model Number 8.0.2 & 8.0.1 with RapiDispense Product Usage: Automated anesthesia cart that monitors and controls the dispensing of... on . FDA classified it as Class II and gives the reason as "The firm issued a clinical alert after users reported an issue where the Anesthesia-Rx system was interrupted ANF became temporarily unavailable during use". As of , the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number
Z-2089-2013
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Mckesson Technologies, Inc.
Product
Mc Kesson Anesthesia-Rx Model Number 8.0.2 & 8.0.1 with RapiDispense Product Usage: Automated anesthesia cart that monitors and controls the dispensing of medications, narcotics and supplies during surgical procedures.
Product code
BRY Cabinet, Table And Tray, Anesthesia
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.
Root cause tag
software
FDA root cause
Software design
Action
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.
Quantity in commerce
106
Distribution
USA Nationwide Distribution in the states AR, MD, NJ, NY, PA, and WV.
Product codes and lots
Model Number (software version) 8.0.2 & 8.0.1 with RapiDispense

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2089-2013
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2089-2013Class IITerminatedVoluntary: Firm initiated