HIGH

Sedecal Easy Moving Plus Mobile X-ray System Recalled for Cleaning Not Water-Resistant Risk (8 Units

Sedecal recalled 8 units of the Easy Moving Plus mobile X-ray system distributed in California, Illinois and New Jersey. The devices are not water-resistant and cleaning must follow the manual to avoid the consequences of improper cleaning. Stop using the device and contact Sedecal SA or your healthcare provider for instructions.

Quick Facts at a Glance

Recall Date
June 10, 2025
Hazard Level
HIGH
Brand
Sedecal
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

Sedecal Easy Moving Plus is a portable, battery-powered mobile X-ray system used in hospitals and clinics for bedside imaging.

Why This Is Dangerous

The device is not water-resistant and must be cleaned strictly according to the manual. Improper cleaning could lead to damage or safety concerns during clinical use.

Industry Context

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

Real-World Impact

Hospitals may need to isolate affected units, adjust cleaning protocols, and coordinate with Sedecal for guidance. The recall affects eight units, potentially increasing downtime and operational disruption.

Practical Guidance

How to identify if yours is affected

  1. Verify device model SM-50HF-B-D-C and KW rating 50G
  2. Check UDI/DI 08436046001527
  3. Inspect serials for 151248, G23340, C05006-W, G22215, G27497/584, 7034, G25402, G25910

Where to find product info

FDA recall page and Sedecal communications to consignees

What timeline to expect

No specific replacement or refund timeline is provided

If the manufacturer is unresponsive

  • Escalate to hospital risk management
  • File a formal complaint with FDA if guidance is not provided within a reasonable period
  • Document all communications with Sedecal and the institution

How to prevent similar issues

  • Strictly follow manual cleaning instructions for all Sedecal X-ray systems
  • Do not use or clean with water if the manual restricts moisture exposure
  • Implement a standard operating procedure for cleaning in radiology departments
  • Verify device specifications against recall notices before any cleaning or maintenance

Documentation advice

Keep recall notice, purchase records, serials, UDI, and all communication with Sedecal and healthcare providers for liability and warranty purposes

Product Details

Model numbers and identifiers: SM-50HF-B-D-C; 50KW 50G. UDI/DI 08436046001527. Serial numbers listed: 151248. Other identifiers include G23340, C05006-W, G22215, G27497/584, 7034, G25402, G25910. Quantity: 8 units. Distribution: United States in CA, IL, NJ. Sold/used in healthcare settings. No price information provided. Sold in the US market; recall date 2025-06-10. Status: ACTIVE.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 8 total units recalled
  • Recall date 2025-06-10
  • Model numbers: SM-50HF-B-D-C; 50KW 50G
  • UDI/DI 08436046001527
  • Serials: 151248; G23340; C05006-W; G22215; G27497/584; 7034; G25402; G25910
  • Distributed in CA, IL, NJ (US)
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
OTHER

Product Classification

Product TypeMobile X-ray system
Sold At
Multiple Retailers

Product Details

Brand
Sedecal
Model Numbers
SM-50HF-B-D-C
50KW 50G
UDI/DI 08436046001527
151248
G23340
+6 more
Affected States
CA, IL, NJ
Report Date
October 29, 2025
Recall Status
ACTIVE

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