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.
This recall has been terminated (originally issued July 13, 2015).
- Company
- Agfa Healthcare Corp.
- Recall Initiated
- June 26, 2015
- Posted
- July 13, 2015
- Terminated
- January 27, 2016
- Recall Number
- Z-2061-2015
- Quantity
- 2
- Firm Location
- Greenville, SC
- Official Source
- View on FDA website ↗
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.
Distribution
Distributed in the state of MO.
Root Cause
Other
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.
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