Z-2552-2011

IMPAX CV (Cardio Vascular) The IMPAX Cardiovascular suite is a cardiovascular information system, providing...

Name: Z-2552-2011 IMPAX CV (Cardio Vascular) The IMPAX Cardiovascular suite is a cardiovascular information system, providing...
Creator: AGFA Corp.
Published: 2011-03-21
License: https://open.fda.gov/license/

AGFA Healthcare Corp. / initiated 2011-03-21 / Terminated / root cause: manufacturing process

FDA source

AGFA Corp. began a recall of IMPAX CV (Cardio Vascular) The IMPAX Cardiovascular suite is a cardiovascular information system, providing archiving, image display and modality/study... on 2011-03-21. The reason FDA records is "Customer error with the angiography (XA: X-Ray Angiography) measurement calibration functionality within the Cardiovascular Review Station resulted in improper calibration". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2552-2011
Status: Terminated
Initiated: 2011-03-21
Posted: 2011-06-10
Terminated: 2011-11-29
Recalling firm: AGFA Healthcare Corp.
Product: IMPAX CV (Cardio Vascular) The IMPAX Cardiovascular suite is a cardiovascular information system, providing archiving, image display and modality/study specific structured reporting.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Customer error with the angiography (XA: X-Ray Angiography) measurement calibration functionality within the Cardiovascular Review Station resulted in improper calibration.
Root cause tag: manufacturing process
FDA root cause: Other
Action: The firm, AGFA Healthcare, sent an "URGENT SAFETY NOTICE" letter dated March 21, 2011 via FED-EX to its customers.. The letter describes product, problem, and actions to be taken. The customers were instructed to distribute this information within their facility to all individuals who need to be aware and to complete and return the URGENT SAFETY NOTICE FEEDBACK FORM via fax to: 864-421-1664 or email. AGFA is supplying the customers with a CRS User Manual Addendum to emphasize the proper steps required to achieve an accurate measurement when using the calibration tool within CRS. Mitigation will provide the customer/end-user with awareness of the correct XA measurement calibration technique and the potential consequences if proper technique is not followed. Additionally, AGFA will offer customer training on the use of the calibration tool. This training will be provided remotely via the web at no cost. Customers were ask to register before May 1, 2011 by contacting AGFA Customer Support Center toll-free at 877-777-2432. Training sessions are from May-June 2011. If you have any questions about this matter, please contact your local AGFA HealthCare organization or the AGFA Customer Support Center at 877-777-2432.
Quantity in commerce: 536
Distribution: Worldwide distribution: USA (nationwide) and country of Canada.
Product codes and lots: Software versions - 2.01.B10, 2.01.B15, 2.01.B25, 2.02.B32, 2.02.B39 2.02.B40, 2.02.B43, 2.03.B16, 2.02.B23, 2.03.B26, 2.03B31.P01, 2.03.B31, 2.04.B03, 2.04.B06, 2.05.B01, 2.04.B07, 2.06.47, 2.06.47.02, 2.05.B02, 2.06.47.08, 2.06.47.08, 2.06.47.08.03, 2.06.47.02, 2.06.47.18, 2.06.47.18.01, 2.06.47.27, 2.06.47.18.02, 2.06.47.30, 2.06.47.37, 2.06.47.40, 2.07.24, 2.08.05.01, 2.07.30.01, 2.07.30.02, 2.05.03.04, 2.09.03, 2.07.30.07, 2.07.35, 2.07.24.SLEH.07, 2.09.04.02, 2.07.35.01, 2.10.06, 2.11.06, 2.05.04.05, 2.12.09, 2.13.08, 2.13.08.SU1, 2.14.03, 2.14.03.SU1, 2.15.08, 2.14.03.SU2, 2.15.08.SU3, 2.16.08, 7.4.SU3, 7.8, 7.8.SU1, and 7.8.SU2

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)