HIGH

SEDECAL Recalls Mobile X-ray System Due to Cleaning Risks

SEDECAL SA recalled four units of its Mobile X-ray system on June 10, 2025, due to water-resistance issues. Improper cleaning can lead to serious safety hazards. Users must stop using the product immediately and follow 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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Product Details

The recall involves the Model Number SM-40HF-B-D-C; 40KW 55C/60C Mobile X-ray system. The affected units have UDI/DI 08436046001510 and serial numbers G35611, G37536, G37588, and G37490. The products were distributed in California, Illinois, and New Jersey.

The Hazard

The Mobile X-ray system is not water-resistant, posing risks if cleaned improperly. The manufacturer issued a reminder about following the cleaning instructions in the user manual.

Reported Incidents

There are no reported incidents of injury or death associated with this recall. The high hazard classification indicates potential for serious safety issues.

What to Do

Stop using the Mobile X-ray system immediately. Follow the instructions provided by SEDECAL SA and consult your healthcare provider for next steps.

Contact Information

For further information, contact SEDECAL SA or refer to the recall notice at the FDA website: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0270-2026.

Key Facts

  • Recall date: June 10, 2025
  • High hazard level
  • Four units recalled
  • Affected regions: CA, IL, NJ

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Safety Assessment

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

Product Details

Model Numbers
UDI/DI 08436046001510
Serial Numbers: G35611
G37536
G37588
G37490.
Affected States
CA, IL, NJ
Report Date
October 29, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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