Agfa N.V.: Medical Device Recall in 2020 - (Recall #: Z-1502-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: February 10, 2020

Date Posted: March 25, 2020

Recall Number: Z-1502-2020

Event ID: 85028

Reason for Recall:

Tomosynthesis image acquisition sequence did not stop automatically after expected number of exposures.

Status: Terminated

Product Quantity: 2 units

Code Information:

Serial Numbers: 00949, 1161

Distribution Pattern:

US Nationwide distribution in the states of FL, VA.

Voluntary or Mandated:

Voluntary: Firm initiated