HIGH

Sedecal SA Recalls 22 SM-32HF-Batt Mobile X-ray Systems for Cleaning Risk (2025)

Sedecal SA recalled 22 SM-32HF-Batt 32KW analog mobile X-ray systems distributed to California, Illinois and New Jersey. The units are not water-resistant and must be cleaned strictly per the manual, with explicit consequences for improper cleaning. Healthcare facilities should stop using the devices immediately and follow the manufacturer's recall instructions 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-32HF-Batt is a mobile X-ray system used in clinical imaging settings. It is designed for point-of-care radiography in hospitals or clinics.

Why This Is Dangerous

The unit is not water-resistant and requires cleaning only per the manual. Improper cleaning could cause equipment damage or safety hazards to patients and staff.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Facilities must halt use of affected devices and follow the manufacturer's recall instructions. No injuries have been reported, but the impact includes potential disruption to imaging services and additional steps for validation.

Practical Guidance

How to identify if yours is affected

  1. Verify model SM-32HF-Batt is on site
  2. Check UDI/DI 08436046001466 and serial numbers listed
  3. Confirm the device’s cleaning procedure aligns with the manual

Where to find product info

Recall notices were sent by email to consignees; FDA recall page Z-0256-2026 contains details

What timeline to expect

Manufacturers typically complete replacements or repairs within weeks to a few months, depending on availability

If the manufacturer is unresponsive

  • Document communication attempts with Sedecal SA
  • File a notice with the local hospital risk management team
  • Escalate to FDA recall office if no response after 4 weeks

How to prevent similar issues

  • When purchasing imaging equipment, verify water-resistance and cleaning protocols
  • Keep manuals accessible and train staff on approved cleaning procedures
  • Monitor recall databases for updates on medical devices
  • Ask manufacturers about post-market service and repair options

Documentation advice

Keep the recall notice, serial numbers, UDI/DI, and all correspondence with Sedecal SA; document service history and downtime during remediation

Product Details

Model: SM-32HF-Batt; 32KW ANALOG, Mobile X-ray system UDI/DI: 08436046001466 Serial Numbers: G-33344, G29404, G29407, G30258, G30236, G63124, G60169, G26234, G26284, G25734, G38069, G-40590, G41143, G62020, G69393, G38082, G41163, G60166, G26244 Sold in: United States (states of California, Illinois, New Jersey) Quantity: 22 units Recall date: 2025-06-10 Status: Active Notes: UDI/DI and serial numbers listed are those associated with affected units

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 22 units recalled
  • Model SM-32HF-Batt; 32KW ANALOG Mobile X-ray System
  • UDI/DI 08436046001466
  • Serials include G-33344, G29404, G29407, G30258, G30236, G63124, G60169, G26234, G26284, G25734, GS?
  • Distributed to 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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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
ELECTRICALOTHER

Product Classification

Product TypeMobile X-ray System
Sold At
Multiple Retailers

Product Details

Model Numbers
SM-32HF-Batt; 32KW ANALOG, Mobile X-ray System
UDI/DI 08436046001466
Affected States
CA, IL, NJ
Report Date
October 29, 2025
Recall Status
ACTIVE

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