The Recall Desk
HighFDA (Devices)·Z-0556-2014·Announced 2014-01-01

McKesson Radiology 12.0 PACS Recall for Missing Contrast Allergy Data

McKesson Information Solutions LLC is recalling McKesson Radiology 12.0 PACS because merging patient records may result in missing contrast allergy information.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (medical device software) where the loss of allergy data poses a safety risk, but no injuries or illnesses have been reported in the source text.

Plain-English summary

McKesson Information Solutions LLC is recalling McKesson Radiology 12.0, Picture Archiving Communication System (PACSA), due to a software defect. The recall involves 6 units of the system.

The defect occurs when two patient records are merged into one. In these instances, the resulting patient record is missing the Contrast Allergy information for the second patient record. This data loss could potentially impact patient safety during procedures involving contrast agents.

The affected units were distributed in Missouri, New York, Tennessee, West Virginia, and France. McKesson Information Solutions LLC is the recalling firm. No specific instructions for consumers or end-users are provided in the source text beyond the identification of the defect.

The recalled product

Product
McKesson Radiology 12.0, Picture Archiving Communication System (PACSA).
Affected units
6

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)

  • MR 12.0

Distribution

Distributed in 4 states: