Z-0556-2014 Class II Terminated

Recalled by Mckesson Information Solutions LLC — Alpharetta, GA

FDA device recall Z-0556-2014 was initiated by Mckesson Information Solutions LLC on October 15, 2013 and is designated Class II. 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. The recall status is terminated (terminated June 3, 2014). Affected quantity: 6 units.

Recall Details

Product Type
Devices
Report Date
January 1, 2014
Initiation Date
October 15, 2013
Termination Date
June 3, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6 units

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.

Distribution Pattern

MO, NY, TN, WV and France.

Code Information

MR 12.0