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IMPAX Agility. IMPAX Agility when deployed as a departmental Picture Archiving and communications system (PACS) provides

FDA device recall Z-2061-2015 · posted 2015-07-13 · Terminated

Recall details

Recalling firm
AGFA Healthcare Corp.
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.
Action taken
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
Status
Terminated
Product code
LLZ
Quantity affected
2
Distribution
Distributed in the state of MO.
Date initiated
2015-06-26
Date posted
2015-07-13
Date terminated
2016-01-27
Location
Greenville, SC

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