HIGH

Sedecal SA Recalled 6 Mobile X-ray Systems for Water-Resistance Cleaning Issue (2025)

Sedecal SA recalled 6 SM-40HF-B-D-C mobile X-ray systems distributed to consignees in California, Illinois and New Jersey after a notice reminded users the devices are not water-resistant and must be cleaned strictly per the manual. The reminder outlined possible consequences of improper cleaning. Hospitals should stop using the devices and follow the manufacturer’s recall instructions.

Quick Facts at a Glance

Recall Date
June 10, 2025
Hazard Level
HIGH
Brand
Sedecal SA
Category
Health & Personal Care
Sold At
Unknown
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 mobile X-ray system is a portable imaging device used in hospitals to perform radiographs at patient bedside or in various clinical settings.

Why This Is Dangerous

Not water-resistant. Cleaning must follow the manual. Improper cleaning may damage the unit or affect performance.

Industry Context

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

Real-World Impact

Equipment damage or malfunction could disrupt imaging services and require service or replacement; no injuries reported yet.

Practical Guidance

How to identify if yours is affected

  1. 1. Confirm model SM-40HF-B-D-C; 40KW.002.
  2. 2. Check serial numbers: G39544, G62558, G71736, G40116, G65568, G65570.
  3. 3. Confirm distribution to CA, IL, NJ.
  4. 4. If affected, stop use and contact the manufacturer for instructions.

Where to find product info

Serial numbers appear on the device label and in the user manual. UDI: 08436046001510.

What timeline to expect

Not specified by the manufacturer.

If the manufacturer is unresponsive

  • Document all communications with the manufacturer.
  • Escalate to hospital administration or procurement.
  • File a report with the FDA if the company remains unresponsive.

How to prevent similar issues

  • Ensure cleaning procedures follow the manual for all similar equipment.
  • Avoid using devices that have damaged seals or water exposure.
  • Review and train staff on cleaning protocols and device handling.

Documentation advice

Keep all recall notices, emails, and manufacturer instructions. Save serial numbers and model details for your records.

Product Details

Model numbers: SM-40HF-B-D-C; 40KW.002. Distribution: US consignees in CA, IL, NJ. Recall date: 2025-06-10. Quantity: 6 units. Sold at: Unknown. Price: Unknown.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 6 units recalled
  • Model SM-40HF-B-D-C; 40KW.002
  • Distributed to CA, IL, NJ
  • Recall date 2025-06-10
  • Hazard: not water-resistant; improper cleaning may damage or affect operation
  • No injuries reported
View Original Recall on FDA - Medical Devices

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Safety Guide

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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
Unknown

Product Details

Model Numbers
SM-40HF-B-D-C
40KW.002
UDI/DI 08436046001510
G39544
G62558
+4 more
Affected States
CA, IL, NJ
Report Date
October 29, 2025
Recall Status
ACTIVE

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