The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1060-2014·Announced 2014-03-12

McKesson Anesthesia Care System Recalled for Data Mismatch

McKesson Technologies is recalling 10 units of the Anesthesia Care system because patient case data did not match the patient data, including data from another case.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "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."

Plain-English summary

McKesson Technologies Inc. is recalling 10 units of the McKesson Anesthesia Care system, software versions MAC 14.3.1 and MAC 14.3.1.1. The system is a computer-based platform used in operating room environments to collect, process, and record anesthesia data, including manual entries and data from patient monitors. It also provides clinical decision support by communicating potential adverse drug event alerts.

The recall was initiated because an occurrence was identified where patient case data did not match the patient data when the case was recalled in the Anesthesia Care Record (ACR). Specifically, the recalled case included data from another case. This data integrity issue could lead to incorrect documentation of patient care.

The affected units were distributed nationwide, including in California, Georgia, Indiana, Kentucky, Maryland, Michigan, Ohio, Oklahoma, and Washington. Healthcare facilities using this system should verify their software version and contact McKesson Technologies for further instructions on resolving the data mismatch issue.

The recalled product

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.…
Manufacturer
MCKESSON TECHNOLOGIES INC.
Category
Medical Device — Anesthesia Information Management System
Hazard
Affected units
10

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • MAC 14.3.1/MAC 14.3.1.1

Distribution

Distributed nationwide across the United States.

The notice also names 9 states specifically:

Related recalls

Same manufacturer · MCKESSON TECHNOLOGIES INC.

See all →

Same hazard · data integrity

See all →

Similar recalls