Recall Z-1060-2014— MCKESSON TECHNOLOGIES INC.

Name: FDA recall Z-1060-2014
Creator: U.S. Food and Drug Administration
Published: 2013-03-15

Class I · Terminated

Class I FDA medical device recall by MCKESSON TECHNOLOGIES INC., initiated 2013-03-15, terminated 2014-05-01. It names one FDA 510(k) clearance: K113633. Product: 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: 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..

Recalling firm: MCKESSON TECHNOLOGIES INC.
Classification: Class I
Status: Terminated
Initiated: 2013-03-15
Terminated: 2014-05-01
Firm location: Durham, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K113633 — MCKESSON ANESTHESIA CAREMckesson Technologies, Inc.·cleared 2012-04-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.