AGFA Healthcare Corp. Recalls

All product recalls associated with AGFA Healthcare Corp..

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Recall Summary

Total Recalls

32

Past Year

1

Class I (Serious)

0

Most Recent

Nov 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–20 of 32 recalls

Brand name: AGFA Digital Radiography X- Ray system DR 800... (AGFA Healthcare Corp.) – it is possible to exceed the maximum ... (2025)

It is possible to exceed the maximum allowed Air Kerma rate (AKR) of 88mGy/min for pulsed fluoro exams. This can happen in case the framerate is increased on the NX workstation when ABS is not enabled.

Moderate

FDANov 18, 2025Nationwide• AGFA Healthcare Corp.

AGFA Healthcare Corp.: Radiomat M+ NIF 14 x 17, Radiomat M+ NIF 35CM x 43CM, Rad...

Some material of the coating Type CXCPMV3 has potential artifacts showing a small bright thin line when the film is processed.

Class IIILow

FDAOct 24, 2014Nationwide• AGFA Healthcare Corp.

AGFA Healthcare Corp.: Radiomat M+ NIF 14 x 17; Radiomat SG 14 x 17 NIF; RX-B 8 ...

Some sheets of the medical screen film are fogged.

Class III

Low

FDAJul 16, 2014Nationwide• AGFA Healthcare Corp.

AGFA Corp.: Agfa Impax R6.3 DB Server. Impax Systems are Picture Arc...

Measurements are inaccurate on multiple workstations.

FDAJul 16, 2009Nationwide• AGFA Corp.

AGFA Corp.: NX 2008 Central Monitoring System (CMS). Product code: ...

After opening and closing a study on a Central Monitoring System while a study is still open on an in-room NX system, a problem of image mix-up can occur on the in-room NX system.

FDAJun 22, 2009IL, PA, TX• AGFA Corp.

AGFA Corp.: AGFA IMPAX HeartStation ECG Management System.

HeartStation does not refresh content changes to the PDF reports that are printed emailed or faxed from the Index page. This may lead to a discrepancy in patient demographics between what is displayed in the HeartStation Client interface and the report delivered to the consumer. Questions are being directed to the local Agfa representative; the contact information was included in the letter.

FDAMay 7, 2009CA, KY, MA +3 more• AGFA Corp.

AGFA Corp.: IMPAX CV Results Manager/Results Manager Administration T...

User could modify a measurement's units and that change would not be reflected in echocardiography formulas used within the Adult echocardiography RM.

FDAApr 15, 2009Nationwide• AGFA Corp.

AGFA Corp.: IMPAX Cardiovascular Polling Procedure version 1.00.09, u...

Polling procedure may fail when multiple merge/split is carried out.

FDADec 24, 2008Nationwide• AGFA Corp.

AGFA Corp.: Impax 6.x Clients including: 6.3 all versions below 6.3.1...

The IMPAX client failed to "refresh" the image area upon receiving a study retrieved from archive. The system also erroneously displays this study retrieved from archive as the "active" study.

FDAJun 4, 2008Nationwide• AGFA Corp.

AGFA Corp.: Drystar AXYS, Hardcopy Printer A free standing device us...

The "Film Calibration" setting on the printers was set to the default "OFF" position instead of "ON".

FDAMay 16, 2008DE, FL, IL +16 more• AGFA Corp.

AGFA Corp.: Agfa IMPAX CardioVascular Suite Results Management Nuclea...

Reporting Differences: The Outbound Report software produces an Outbound Report (text version) which does not contain all the clinical content elements present in the PDF version of the report, also generated on the Nuclear Cardiology Reporting Module.

FDAFeb 22, 2008Nationwide• AGFA Corp.

AGFA Corp.: IMPAX 6.2.1 Network Gateway Server, License Key. Catalog...

Failure of Data Transmission: No imaging data could be transmitted by the device, because a key value needed for data transmission was incorrectly entered in the affected units by AGFA Healthcare.

FDADec 11, 2007Nationwide• AGFA Corp.

AGFA Corp.: Agfa Heartlab Cardiovascular Results Management Product: ...

Incorrect Results: Erroneous echocardiographic measurement values due to mathematical formula being mis-configured.

FDAJul 27, 2007Nationwide• AGFA Corp.

AGFA Corp.: IMPAX 6.2.1 System, Picture Archiving and Communications ...

Text and Images may not be synchronized.

FDAJun 28, 2007Nationwide• AGFA Corp.

AGFA Corp.: Agfa HeartLab Cardiovascular DICOMstore Version 2.04.40.0...

MIsidentification: The electrocardiogram (ECG) data of one patient is misidentified as the data of another patient.

FDAJun 21, 2007AZ, CA, FL +17 more• AGFA Corp.

AGFA Corp.: WEB1000 Versions 3.1, 4.1 and 5.1, Picture Archiving and ...

Java version 1.6x (JAVA 6) is not compatible with AGFA IMPAX Administration/Service Tools. Due to a Software Mismatch data can be lost.

FDAMay 14, 2007Nationwide• AGFA Corp.

AGFA Corp.: IMPAX 4.1, IMPAX 4.5, IMPAX 5.0, IMPAX 5.1 IMPAX 5.2,...