Recall Z-2061-2015 ยท LLZ System, Image Processing, Radiological
AGFA Healthcare Corp.
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.
| Date | Jul 13, 2015 (initiated Jun 26, 2015) |
| Status | Terminated |
| 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. |
| Root cause | Other |
| 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. |
| Quantity | 2 |
| Distribution | Distributed in the state of MO. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.