Recall Z-1060-2014 ยท BSZ Gas-Machine, Anesthesia
MCKESSON TECHNOLOGIES INC.
McKesson Anesthesia Care Product Usage: The McKesson Anesthesia Care system is a computer based system which collects, processes,and records data both through manual entry and from monitors which themselves are attached to patients, such as in the operating room environment. The system provides clinical decision support by communicating potential Adverse Drug Event alerts proactively during the
| Date | Mar 5, 2014 (initiated Mar 15, 2013) |
| Status | Terminated |
| Reason | There was an occurrence where the patient case data did not match the patient data when the case was recalled in the Anesthesia Care Record (ACR) in that it included data from another case. |
| Root cause | Software design |
| Action | McKesson sent a Clinical Alert dated March 15, 2013 to all affected customers. Additionally, phone calls were placed to each customer, followed up by an email to provide them written copies of the communication and Clinical Alert and obtaining acknowledgement that they have read and understand the issue and preventive actions to take. Customers with questions were instructed to contact McKesson Customer Support at 800-442-6767 (option 3). For questions regarding this recall call 404-338-3556. |
| Quantity | 10 |
| Distribution | Nationwide Distribution including CA, GA, IN, KY, MD, MI, OH, OK, and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113633 | MCKESSON ANESTHESIA CARE Mckesson Technologies, Inc., Apr 20, 2012 |