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Recall Observatory FDA recall evidence

Device product

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

Z-0556-2014

October 15, 2013

Class II

Product summary

Firm
Mckesson Information Solutions LLC
Event
Event 67014
Status
Terminated
Classification
Class II
Quantity
6 units
Official record key
device-enforcement:Z-0556-2014

Official wording

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.

Code information: MR 12.0

Distribution pattern: MO, NY, TN, WV and France.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.