Z-1060-2014 Class I Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 12, 2014
- Initiation Date
- March 15, 2013
- Termination Date
- May 1, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10
Product Description
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 pre-anesthesia evaluation and at the point-of-care. The system is generally indicated in the anesthetizing environment when the anesthesia provider decides to perform a patient assessment, to generate a paper and/or electronic record of the administration of anesthesia to a patient, and to document care.
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.
Distribution Pattern
Nationwide Distribution including CA, GA, IN, KY, MD, MI, OH, OK, and WA.
Code Information
MAC 14.3.1/MAC 14.3.1.1