Z-1502-2020Class II

AGFA Digital Radiography X- Ray system DR 800 with TomoSynthesis- a Tomographic X-ray system -

Name: Z-1502-2020 AGFA Digital Radiography X- Ray system DR 800 with TomoSynthesis- a Tomographic X-ray system -
Creator: Agfa N.V.
Published: 2020-02-10
License: https://open.fda.gov/license/

Agfa N.V. / initiated 2020-02-10 / Terminated

FDA source

Agfa N.V. began a recall of AGFA Digital Radiography X- Ray system DR 800 with TomoSynthesis- a Tomographic X-ray system - Product Usage: TomoSynthesis is used to synthesize tomographic... on 2020-02-10. FDA classified it as Class II and gives the reason as "Tomosynthesis image acquisition sequence did not stop automatically after expected number of exposures". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1502-2020
Classification: Class II
Status: Terminated
Initiated: 2020-02-10
Posted: 2020-03-18
Terminated: 2023-03-30
Recalling firm: Agfa N.V.
Product: AGFA Digital Radiography X- Ray system DR 800 with TomoSynthesis- a Tomographic X-ray system - Product Usage: TomoSynthesis is used to synthesize tomographic slices from a single tomographic sweep. The DR 800 is not intended for mammography applications
Product code: IZF System, X-Ray, Tomographic
Reason for recall: Tomosynthesis image acquisition sequence did not stop automatically after expected number of exposures.
FDA root cause: Under Investigation by firm
Action: AFGA issued via email On February 10, 2020, an URGENT FIELD SAFETY NOTICE letter. Letter states reason for recall, health risk, and action to take: With this letter, Agfa is informing you that the DR 800 system still can be used including for Tomosynthesis for mAs values which are larger than 0,2 mAs. In case Tomosynthesis image acquisition sequence does not stop automatically after the expected number of exposures, release the exposure button as this will stop the sequence and notify your Agfa Service contact at once. Contact your local Agfa Imaging organization 1-877-777-2432 and please reference Problem Record PRB2000387 and Vigilance Record VR0000716. Complete/Return by fax or email the URGENT FIELD SAFETY NOTICE Feedback form
Quantity in commerce: 2 units
Distribution: US Nationwide distribution in the states of FL, VA.
Product codes and lots: Serial Numbers: 00949, 1161

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1502-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1502-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-25	2020-03-18

Product code IZF

K183275Class IIDR 800 with TomosynthesisAgfa N.V. / cleared 2019-02-01

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)