McKesson Anesthesia Care Product Usage: The McKesson Anesthesia Care system is a computer based system which collects, p
FDA device recall Z-1060-2014 · posted 2014-03-05 · Terminated
Recall details
- Recalling firm
- MCKESSON TECHNOLOGIES INC.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- BSZ
- Quantity affected
- 10
- Distribution
- Nationwide Distribution including CA, GA, IN, KY, MD, MI, OH, OK, and WA.
- Date initiated
- 2013-03-15
- Date posted
- 2014-03-05
- Date terminated
- 2014-05-01
- Location
- Durham, NC
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MCKESSON ANESTHESIA CARE (K113633) | Mckesson Technologies, Inc. | 2012-04-20 |