HIGH

Sedecal Mobile X-ray System Recall: 3 Units Not Water-Resistant (2025)

Sedecal SA recalled 3 units of the SM_40HF_B_D_VIR3.004 Mobile X-ray system distributed to consignees in California, Illinois and New Jersey. The devices are not water-resistant and must be cleaned strictly per the manual. Patients and healthcare providers should stop using the device immediately and follow recall instructions.

Quick Facts at a Glance

Recall Date
June 10, 2025
Hazard Level
HIGH
Brand
Sedecal
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
3 states
At-Risk Groups
GENERAL

Hazard Information

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact SEDECAL SA or your healthcare provider for instructions. Notification method: E-Mail

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About This Product

The SM_40HF_B_D_VIR3.004 is a mobile X-ray system used in clinical settings to perform radiographs at the point of care.

Why This Is Dangerous

The unit is not water-resistant and requires cleaning per the manual. Improper cleaning could compromise device integrity or patient safety.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Three units are affected. Hospitals should stop use and follow recall instructions to prevent potential device damage or patient safety issues.

Practical Guidance

How to identify if yours is affected

  1. Locate the model SM_40HF_B_D_VIR3.004 on the device tag
  2. Check the UDI/DI: 08436046002166
  3. Verify serial numbers: G73023, G87352, G80066

Where to find product info

UDI/DI and serial numbers are on the device label and in the user manual PDF.

What timeline to expect

Not specified in the recall notice.

If the manufacturer is unresponsive

  • Document all attempts to contact Sedecal SA
  • Escalate to the facility's risk management or biomedical engineering team
  • Consider filing a complaint with the FDA if the vendor is unresponsive

How to prevent similar issues

  • Follow the manual for cleaning to prevent damage
  • Verify device status before use in clinical settings
  • Maintain documentation for all recall communications

Documentation advice

Keep the recall notice, emails, and any responses from Sedecal SA; photograph serial/UDI labels for records

Product Details

Product: SM_40HF_B_D_VIR3.004 Mobile X-ray system Model/UDI: UDI/DI 08436046002166 Serial numbers: G73023, G87352, G80066 Sold in US states: CA, IL, NJ Quantity: 3 units Distribution: US Recall date: 2025-06-10 Manufacturer: Sedecal SA Price: Unknown

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 3 units recalled
  • Model/UDI: 08436046002166
  • Serials: G73023, G87352, G80066
  • Distributed to CA, IL, NJ
  • Recall date: 2025-06-10
  • Not water-resistant; cleaning per manual
View Original Recall on FDA - Medical Devices

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Safety Guide

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Safety Assessment

Risk LevelHIGH
Severity Score
5/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeMobile X-ray system
Sold At
Multiple Retailers

Product Details

Brand
Sedecal
Model Numbers
SM_40HF_B_D_VIR3.004
08436046002166
G73023
G87352
G80066
Affected States
CA, IL, NJ
Report Date
October 29, 2025
Recall Status
ACTIVE

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