Z-0919-2014Class II

Impax Ris Qdoc 5.8

Name: Z-0919-2014 Impax Ris Qdoc 5.8
Creator: AGFA Corp.
Published: 2014-01-08
License: https://open.fda.gov/license/

AGFA Healthcare Corp. / initiated 2014-01-08 / Terminated

FDA source

AGFA Corp. began a recall of IMPAX RIS QDOC 5.8 on 2014-01-08. FDA classified it as Class II and gives the reason as "Patient name displayed (printed) on the Patient Report was the wrong patient name". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0919-2014
Classification: Class II
Status: Terminated
Initiated: 2014-01-08
Posted: 2014-02-03
Terminated: 2014-02-28
Recalling firm: AGFA Healthcare Corp.
Product: Impax Ris Qdoc 5.8
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Patient name displayed (printed) on the Patient Report was the wrong patient name.
FDA root cause: Unknown/Undetermined by firm
Action: On January 8, 2014, an "URGENT FIELD SAFETY NOTICE" (UFSN) letter was emailed to consignees. The letter described the safety alert and mitigation, including directions to consignees as to how the disable Microsoft Word Background Printing. Acknowledgment via FAX-Back or email, that the information was received and understood was requested from the consignees.
Quantity in commerce: 14
Distribution: CA, FL, GA, ME, OH, OR, SC, SD, TX and Canada
Product codes and lots: Software IMPAX RIS 58 and higher

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0919-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0919-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-12	2014-02-03

Product code LLZ

K111945Class IIImpax Next GenerationAgfa Healthcare N.V. / cleared 2011-08-05

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)