HIGH

Sedecal SA Recalls 17 SM_40HF_B_D_VIR3 Mobile X-ray Systems Over Water-Resistance Cleaning Risk (202

Sedecal SA recalled 17 SM_40HF_B_D_VIR3 Mobile X-ray systems distributed in California, Illinois and New Jersey after emailing consignees that the equipment is not water-resistant and must be cleaned exactly as the manual directs. The notices warn about consequences of improper cleaning. Hospitals and clinics should stop using the device and follow the recall instructions from Sedecal SA or their

Quick Facts at a Glance

Recall Date
June 10, 2025
Hazard Level
HIGH
Brand
Sedecal SA
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 is described as a portable X-ray system used in medical facilities for bedside imaging.

Why This Is Dangerous

Not water-resistant. Cleaning must follow the manual. Improper cleaning may lead to adverse outcomes as outlined by the manufacturer.

Industry Context

This recall is not stated as part of a broader industry pattern.

Real-World Impact

Hospitals and clinics with these units should stop use and await further instructions. Service disruption may occur until the device is remediated.

Practical Guidance

How to identify if yours is affected

  1. Identify model SM_40HF_B_D_VIR3 and serial numbers listed above. Check the UDI 08436046002166.
  2. Compare your unit against the listed serials to determine exposure.
  3. Review the recall notice from FDA for Z-0284-2026.

Where to find product info

FDA enforcement page and Sedecal SA notice for recall details.

What timeline to expect

Remedy processing timelines are not provided in the data. Expect updates from Sedecal SA and the FDA.

If the manufacturer is unresponsive

  • File a complaint with Sedecal SA, seek guidance from your healthcare provider, and contact the FDA for consumer questions.
  • Consider legal counsel if there are injuries or unresponsive manufacturers.

How to prevent similar issues

  • Follow the manual's cleaning instructions precisely.
  • Avoid water exposure on this device.
  • Verify any cleaning agents with the manufacturer before use.
  • Document cleaning events and any communications.

Documentation advice

Keep recall notice, serial numbers, UDI, and all correspondence with Sedecal SA and healthcare providers.

Product Details

Model numbers: UDI/DI 08436046002166; Serial Numbers: G86476, G86632, G86634, G85447, G86619, G85453, G85461, G86477, G86633, G87334, G87335, G87336, G87353, G86617, G87337, G85335, G85452.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 17 units recalled
  • Model/UDI and serial numbers published
  • Active recall status as of 2025-10-29
  • Immediate action required: stop use and follow manufacturer instructions
  • FDA recall reference: Z-0284-2026
View Original Recall on FDA - Medical Devices

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Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeMobile X-ray System
Sold At
Multiple Retailers

Product Details

Model Numbers
UDI/DI 08436046002166
G86476
G86632
G86634
G85447
+13 more
Affected States
CA, IL, NJ
Report Date
October 29, 2025
Recall Status
ACTIVE

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