HIGH

Sedecal SM-40HF-B-D-C 40KW Mobile X-ray System Recalled for Cleaning Water-Resistance Issue (2025)

Sedecal SA recalled 39 mobile X-ray systems due to a cleaning instruction issue that could cause improper maintenance. The recall affects units in the US and Canada. An email to consignees emphasizes the device is not water-resistant and must be cleaned per the manual, outlining potential consequences of improper cleaning. Healthcare facilities should stop using the device immediately and followSE

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, PREGNANT, ELDERLY

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 Sedecal SM-40HF-B-D-C is a 40KW, 50G portable X-ray system used in medical imaging to perform radiographs at patient bedsides or in clinics.

Why This Is Dangerous

The device is not water-resistant. The manual requires strict cleaning procedures. Improper cleaning could affect device performance or safety.

Industry Context

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

Real-World Impact

Facilities must halt use and follow recall guidance. The action could disrupt imaging workflows and require device replacement or service coordination.

Practical Guidance

How to identify if yours is affected

  1. Identify model SM-40HF-B-D-C on the device label
  2. Review serial numbers such as G25456, G25508, G25681, G25698, G25930, G27630, G27705, C-25709, G22652, G38643, G25673, G27664, G25708, G25689, G25457, C08042, G25641, G25663, G24234
  3. Confirm distribution region includes US CA IL NJ

Where to find product info

The FDA enforcement page for recall Z-0258-2026 and Sedecal communications

What timeline to expect

Refunds or replacements timelines are determined by Sedecal; monitor official updates

If the manufacturer is unresponsive

  • Document all communications with Sedecal
  • Contact the healthcare facility administrator for escalation
  • File a complaint with the FDA if needed

How to prevent similar issues

  • Verify cleaning guidelines before operating any non-water-resistant medical device
  • Maintain updated device manuals and recall notices
  • Establish a clear chain of communication with manufacturers

Documentation advice

Keep emails, recall notices, serial numbers, and service records as part of the recall file

Product Details

Model Number SM-40HF-B-D-C; 40KW 50G mobile X-ray system. Quantity: 39 units. Distribution: United States and Canada (CA, IL, NJ). Recall date: 2025-06-10. Status: Active.

Reported Incidents

No formal incident counts of injuries or damages are provided in the recall notice. The hazard is described in terms of potential consequences of improper cleaning rather than documented injuries.

Key Facts

  • 39 units recalled
  • Distribution includes US states CA, IL, NJ
  • Model SM-40HF-B-D-C, 40KW 50G
  • Hazard linked to improper cleaning of non-water-resistant device
  • Recall status ACTIVE as of 2025-10-29
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
GENERALPREGNANTELDERLYPREGNANT
Injury Types
ELECTRICALBURNOTHER

Product Classification

Product TypeMobile X-ray system
Sold At
Unknown

Product Details

Model Numbers
SM-40HF-B-D-C
UDI/DI 08436046001510
G25456
G25508
G25681
+16 more
Affected States
CA, IL, NJ
Report Date
October 29, 2025
Recall Status
ACTIVE

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