Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

McKesson Radiology 12.0, Picture Archiving Communication System (PACSA).

FDA Recall Z-0556-2014 · Posted 2013-12-20

Recall StatusTerminated
Product CodeLLZ
Date Initiated2013-10-15
Date Terminated2014-06-03
Product Quantity6 units

Reason for Recall

When merging two patient records into one patient record using McKesson Radiology 12.0, the resulting patient record is missing the Contrast Allergy information for the second patient record.

Firm Action

Consignees were notified via letter (Field Safety Notice) on 10/15/2013.

Root Cause

Other

Distribution Pattern

MO, NY, TN, WV and France.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑