The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2045-2023·Announced 2023-07-05

Mobile Digital X-Ray System Recall: Software Login Issue Affects Units

SEDECAL SA is recalling 1,061 wDR 2.2 Mobile Digital Diagnostic X-Ray Systems due to a software login issue that may prevent users from logging in. The affected units are distributed in the United States and over 70 countries internationally.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is a Class II medical device recall with no reported illnesses, injuries, or hospitalizations. The hazard is a software login functionality issue rather than a direct patient safety threat. The lack of adverse event reports and the functional nature of the defect warrant a Moderate severity rating.

Plain-English summary

SEDECAL SA is recalling 1,061 units of the wDR 2.2 Mobile Digital Diagnostic X-Ray System worldwide. The recall affects Model Numbers 712007, 712006, 712004, and 712002 with specific software versions 2.1 and 2.2.x.

The device software has a login issue that may prevent users from logging in. This functionality issue could impair access to the diagnostic X-ray system.

The recalled units are distributed throughout the United States, including Puerto Rico and the U.S. Virgin Islands. International distribution includes over 70 countries across Europe, Asia, Africa, and the Americas.

Users should contact SEDECAL SA or the FDA for information about corrective actions or replacement units. Healthcare facilities and users should verify whether their units are affected by checking the model and software version.

The recalled product

Product
wDR 2.2 Mobile Digital Diagnostic X-Ray System
Manufacturer
SEDECAL SA
Category
Medical Device — Diagnostic Imaging
Hazard
Affected units
1,061

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (8)

  • Model MobileDiagnost wDR: 1) Model Number 712007
  • Software versions 2.2.0
  • 2.2.1
  • 2.2.2
  • and 2.2.3 2) Model Number 712006
  • and 2.2.3 3) Model Number 712004
  • Software version 2.1 with Windows 10 Upgrade 4) Model Number 712002
  • Software version 2.1 with Windows 10 Upgrade

Distribution

Distributed in 2 states:

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