Z-2061-2015Class II

IMPAX Agility. IMPAX Agility when deployed as a departmental Picture Archiving and communications system...

Name: Z-2061-2015 IMPAX Agility. IMPAX Agility when deployed as a departmental Picture Archiving and communications system...
Creator: AGFA Healthcare Corp.
Published: 2015-06-26
License: https://open.fda.gov/license/

AGFA Healthcare Corp. / initiated 2015-06-26 / Terminated

FDA source

AGFA Healthcare Corp. began a recall of IMPAX Agility. IMPAX Agility when deployed as a departmental Picture Archiving and communications system (PACS) provides an interface for the acquisition... on 2015-06-26. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2061-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-26
Posted: 2015-07-13
Terminated: 2016-01-27
Recalling firm: AGFA Healthcare Corp.
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.
Product code: LLZ System, Image Processing, Radiological
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.
FDA 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 in commerce: 2
Distribution: Distributed in the state of MO.
Product codes and lots: N/A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2061-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2061-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-22	2015-07-13

Product code LLZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)