Facility

AGFA HEALTHCARE INC.

15 recall(s) on record — most severe on record: Class II.

Key facts

15recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3008794078
Establishment type	Develop Specifications But Do Not Manufacture At This Facility
Location	375 Hagey Boulevard WATERLOO Ontario, CA N2L 6R5
Registration status	Active · expires 2026
Parent company	AGFA HEALTHCARE N.V. (owner-operator 9011611)
Brand names	IMPAX PET & SPECT Viewing; IMPAX Registration & Fusion

Activity by year

Recalls (15)

Devices registered here (1)

System, Image Processing, Radiological
Product code LLZ (opens in a new tab) · Class II · Radiology · 21 CFR 892.2050

Recalls & enforcement

20251 record

Class IIOngoing2025-11-18
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.

20241 record

Class IIOngoing2024-09-06
Software defect, when an image has non-square pixel spacing, the reference/localizer line is incorrectly placed on the scout image in the XERO Viewet, may display the incorrect crosshair/line position on the non-coplanar/scout image with respect to the axial slice location. Inacc…

20221 record

Class IIOngoing2022-12-05
There is a software defect that can cause issues with images.

20181 record

Class IITerminated2018-08-03
Adding an additional comparison study to the Clinical Side Bar in the Enterprise Imaging Diagnostics Desktop, can result in a change of the sort order of the studies in the Clinical Side Bar. The thumbnail images of the studies are no longer chronologically sorted with the most r…

20164 records

Class IITerminated2016-12-22
A customer experienced when using IMPAX CV Reporting software, specifically, when building a NIV report, the NIV Cardio report was showing incorrect findings for Aneurysm.
Class IITerminated2016-12-21
A customer reported that when using an NX workstation with software version NX 3.0.8950 software and selecting the affected patient/exam from closed exams, initially the wrong image was linked to the exam and appeared. After a short time the wrong image was replaced by the corre…
Class IITerminated2016-05-02
One of the dent markers from the DX-D600 dropped down from the overhead rail.
Class IITerminated2016-01-20
The DX-D100 User Manual already contained information about to move a DX-D100 mobile unit manually by using an Allen wrench, but did not indicate where the Allen wrench should be stored.

20153 records

Class IITerminated2015-09-01
Customers have experienced IMPAX CV software, specifically, Demographics Manager (DM), not producing correct pdf reports after the reports, at the time of physician signature, were correct.
Class IITerminated2015-06-26
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.
Class IITerminated2015-05-29
When using the DX-D 100 unit, sporadic unintended movements caused by an electrostatic discharge of the unit to the ground may occur.

20144 records

Class IIITerminated2014-10-24
Some material of the coating Type CXCPMV3 has potential artifacts showing a small bright thin line when the film is processed.
Class IIITerminated2014-07-16
Some sheets of the medical screen film are fogged.
Class IITerminated2014-07-02
Some customers reported that while using the DX-D600 in room or exam preparation, the Overhead Tube Crane (OTC) showed increased velocity and uncontrolled longitudinal movement.
Class IIITerminated2014-05-13
Unit was mislabeled with a factory label showing 32 KW output power.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “AGFA HEALTHCARE INC. (FEI 3008794078) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3008794078-agfa-healthcare-inc/

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