Z-1676-2011

IMPAX Remote Cardiology Review Station, a cardiovascular information system. Model Number CV7.8

Name: Z-1676-2011 IMPAX Remote Cardiology Review Station, a cardiovascular information system. Model Number CV7.8
Creator: AGFA Corp.
Published: 2011-02-10
License: https://open.fda.gov/license/

AGFA Healthcare Corp. / initiated 2011-02-10 / Terminated / root cause: design

FDA source

AGFA Corp. began a recall of IMPAX Remote Cardiology Review Station, a cardiovascular information system. Model Number CV7.8 on 2011-02-10. The reason FDA records is "A discrepancy in the validation testing which resulted in the product not performing as intended". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1676-2011
Status: Terminated
Initiated: 2011-02-10
Posted: 2011-03-16
Terminated: 2011-09-15
Recalling firm: AGFA Healthcare Corp.
Product: IMPAX Remote Cardiology Review Station, a cardiovascular information system. Model Number CV7.8
Product code: LLZ System, Image Processing, Radiological
Reason for recall: A discrepancy in the validation testing which resulted in the product not performing as intended.
Root cause tag: design
FDA root cause: Device Design
Action: AGFA sent an "URGENT SAFETY NOTICE" letter dated 2/10/11 via FED-EX to the customer. The letter included an acknowledgment which was to be FAX-Back indicating that the information was received and understood. Agfa has discussed with the customer how the de-installation of their CRS Remote product - Software Version 7.8_HL would be performed.
Quantity in commerce: One
Distribution: TX
Product codes and lots: Model Number CV7.8 Catalog Number CM 60+ 00091915, Software Version CRS Remote_7.8_HL

Product code LLZ

K050228Class IIAgfa Heartlab CardiovascularHeartlab, Inc. / cleared 2005-02-18

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)