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U.S. Department of Health and Human Services

Class 2 Device Recall Mc Kesson AnesthesiaRx

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 Class 2 Device Recall Mc Kesson AnesthesiaRxsee related information
Date Initiated by FirmJuly 22, 2013
Date PostedAugust 26, 2013
Recall Status1 Terminated 3 on June 19, 2014
Recall NumberZ-2089-2013
Recall Event ID 65769
Product Classification Cabinet, table and tray, anesthesia - Product Code BRY
ProductMc 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.
Code Information Model Number (software version) 8.0.2 & 8.0.1 with RapiDispense
FEI Number 3003781505
Recalling Firm/
Manufacturer		 MCKESSON TECHNOLOGIES INC
5995 Windward Pkwy
Alpharetta GA 30005-4184
For Additional Information ContactMcKesson Customer Support
800-700-8737
Manufacturer 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.
FDA Determined
Cause 2		Software design
ActionMcKesson 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 Commerce106
DistributionUSA Nationwide Distribution in the states AR, MD, NJ, NY, PA, and WV.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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