Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1502-2020 — 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

U.S. FDA — Device Enforcement · Belgium · 2020-02-10 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1502-2020
Date of alert
2020-02-10
Country / jurisdiction
Belgium
Risk level
Class II
Risk type
recall
Brand
Agfa N.V.
Product category
device
Product type
Devices
Reported risk: Tomosynthesis image acquisition sequence did not stop automatically after expected number of exposures.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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