Recall Z-0556-2014— Mckesson Information Solutions LLC

Name: FDA recall Z-0556-2014
Creator: U.S. Food and Drug Administration
Published: 2013-10-15

Class II · Terminated

Class II FDA medical device recall by Mckesson Information Solutions LLC, initiated 2013-10-15, terminated 2014-06-03. It names one FDA 510(k) clearance: K043146. Product: McKesson Radiology 12.0, Picture Archiving Communication System (PACSA).. Reason: 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..

Recalling firm: Mckesson Information Solutions LLC
Classification: Class II
Status: Terminated
Initiated: 2013-10-15
Terminated: 2014-06-03
Firm location: Alpharetta, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K043146 — HORIZON MEDICAL IMAGINGMckesson Medical Imaging Company·cleared 2005-01-04

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 Radiology 12.0, Picture Archiving Communication System (PACSA).

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.

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