Reported Jul 5, 2023 · Ongoing

wDR 2.2 Mobile Digital Diagnostic X-Ray System

Sedecal Sa

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: SEDECAL SA · PELAYA, 9 POL. · Algete, N/A · N/A

Is this the product you have?

  • wDR 2.2 Mobile Digital Diagnostic X-Ray System
Lot codes and dates

4 of 4 products

Products covered by this recall
Model / numberProduct as published
712007Software versions 2.2.0, 2.2.1, 2.2.2, and 2.2.3
712006Software versions 2.2.0, 2.2.1, 2.2.2, and 2.2.3
712004Software version 2.1 with Windows 10 Upgrade
712002Software version 2.1 with Windows 10 Upgrade
Amount recalled
1061 units

Where it was sold

Why it was recalled

There is a software login in issue that may prevent the user from logging in.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:36 PM UTC

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