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Recall Observatory FDA recall evidence

Device product

IMPAX Agility. IMPAX Agility when deployed as a departmental Picture Archiving and communications system (PACS) provides an interface for the acquisition, display, digital processing, annotation, review, printing, storage and distribution of multimodality medical images, reports and demographic information for diagnostic purposes within the system and across computer networks.

Z-2061-2015

June 26, 2015

Class II

Product summary

Firm
AGFA Healthcare Corp.
Event
Event 71606
Status
Terminated
Classification
Class II
Quantity
2
Official record key
device-enforcement:Z-2061-2015

Official wording

Reason: Firm received a complaint that the hospital had sent two accession numbers over the same morning and on the Agility side the patient name was incorrect.

Code information: N/A

Distribution pattern: Distributed in the state of MO.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Firm received a complaint that the hospital had sent two accession numbers over the same morning and on the Agility side the patient name was incorrect.