HIGH

Sedecal SA Recalls 1 SM-40HF-B-D-C Mobile X-ray System in 2025

Sedecal SA recalled 1 unit of SM-40HF-B-D-C 40KW 55C Mobile X-ray System distributed to CA, IL and NJ. The recall notice warns the device is not water-resistant and must be cleaned strictly per the manual, with explicit consequences for improper cleaning. Facilities and healthcare providers should stop using the device immediately and follow the recall instructions. Notification was sent by email.

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-C is a mobile X-ray system used in medical imaging. It is deployed in healthcare facilities to perform radiographs at patient bedsides or in wards.

Why This Is Dangerous

The device is not water-resistant. Cleaning must follow the manual. Improper cleaning could create safety risks depending on exposure and handling during cleaning.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Healthcare facilities must halt use of this unit to avoid potential safety issues related to improper cleaning. Impact on operations may include sourcing guidance from the manufacturer and temporary imaging delays.

Practical Guidance

How to identify if yours is affected

  1. Verify model SM-40HF-B-D-C on the device label
  2. Check UDI/DI 08436046001510
  3. Check Serial Number G37528
  4. Confirm distribution to CA, IL, NJ
  5. Review the recall notice received by email and FDA page

Where to find product info

Serial number and model are located on the device label near the power/data plate. UDI/DI is listed on the same label.

What timeline to expect

No remedy timeline is provided in the notice. Follow manufacturer instructions for next steps and monitor FDA recall updates.

If the manufacturer is unresponsive

  • Document all contact attempts with SEDECAL SA
  • File a safety report with the FDA if no response after a reasonable period
  • Consult your hospital risk management team for escalation

How to prevent similar issues

  • Do not use devices that are not water-resistant unless manufacturer-approved.
  • Follow the cleaning protocol exactly as described in the manual.
  • Verify device identifications before any cleaning procedures.
  • For future acquisitions, check IP ratings and cleaning guidelines in the manual

Documentation advice

Keep the recall email, the UDI/DI and serial numbers, and all communications with SEDECAL SA. Photograph labels and store copies of all official notices.

Product Details

Model numbers: SM-40HF-B-D-C; UDI/DI: 08436046001510; Serial Numbers: G37528 Where sold/distributed: United States — California, Illinois, New Jersey When sold: Recall Date 2025-06-10; Date sold not specified Price: Unknown

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 1 unit recalled
  • Model SM-40HF-B-D-C
  • UDI/DI 08436046001510
  • Serial Number G37528
  • Distribution: CA, IL, NJ
  • Recall Date 2025-06-10; Status: ACTIVE
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
Multiple Retailers

Product Details

Model Numbers
SM-40HF-B-D-C
UDI/DI 08436046001510
Affected States
CA, IL, NJ
Report Date
October 29, 2025
Recall Status
ACTIVE

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