Z-0556-2014Class II

McKesson Radiology 12.0, Picture Archiving Communication System (PACSA)

Name: Z-0556-2014 McKesson Radiology 12.0, Picture Archiving Communication System (PACSA)
Creator: Mckesson Information Solutions LLC
Published: 2013-10-15
License: https://open.fda.gov/license/

Mckesson Information Solutions, LLC / initiated 2013-10-15 / Terminated

FDA source

Mckesson Information Solutions LLC began a recall of McKesson Radiology 12.0, Picture Archiving Communication System (PACSA) on 2013-10-15. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0556-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-15
Posted: 2013-12-20
Terminated: 2014-06-03
Recalling firm: Mckesson Information Solutions, LLC
Product: McKesson Radiology 12.0, Picture Archiving Communication System (PACSA).
Product code: LLZ System, Image Processing, Radiological
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.
FDA root cause: Other
Action: Consignees were notified via letter (Field Safety Notice) on 10/15/2013.
Quantity in commerce: 6 units
Distribution: MO, NY, TN, WV and France.
Product codes and lots: MR 12.0

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0556-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0556-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-01	2013-12-20

Product code LLZ

K043146Class IIHorizon Medical ImagingMckesson Medical Imaging Company / cleared 2005-01-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)