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Terminated

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.

FDA Recall Z-2061-2015 · Posted 2015-07-13

Recalling FirmAGFA Healthcare Corp.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2015-06-26
Date Terminated2016-01-27
Product Quantity2

Reason for Recall

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.

Firm Action

PRB0046372 was created to address the corrective actions related to this issue. On 6/26/2015, an email communication, as an effectiveness check was sent to the two customers. Acknowledgment, via email, that the communication was received was requested from the consignees.

Root Cause

Other

Distribution Pattern

Distributed in the state of MO.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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