Mc Kesson Anesthesia-Rx Model Number 8.0.2 & 8.0.1 with RapiDispense
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| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2089-2013 | Class II | Terminated | Voluntary: Firm initiated |
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