HIGH

Sedecal Mobile X-ray Systems Recall 6 Units for Cleaning Not Water-Resistant Risk (2025)

Sedecal SA recalled 6 mobile X-ray systems in the United States on June 10, 2025 after warning that the devices are not water-resistant and must be cleaned strictly per the manual. The recall notes possible consequences of improper cleaning. Healthcare facilities should stop using the devices immediately and follow Sedecal's recall instructions.

Quick Facts at a Glance

Recall Date
June 10, 2025
Hazard Level
HIGH
Brand
Sedecal
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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About This Product

Sedecal mobile X-ray systems are used in medical facilities to perform radiographic imaging at the point of care. They are designed for mobility within hospitals and clinics.

Why This Is Dangerous

The device is not water-resistant and must be cleaned exactly as described in the manual. Improper cleaning could compromise device function or safety.

Industry Context

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

Real-World Impact

Facilities may experience downtime during remediation, potential equipment damage if cleaning rules are ignored, and escalation overhead as providers follow recall directions.

Practical Guidance

How to identify if yours is affected

  1. Verify model SM-40HF-B-D-C; 40KW.005
  2. Cross-check serials UDI 08436046001510 and G64274, G40012, G64597, G70742, G72764, G61804
  3. Confirm distribution to CA, IL, NJ; check internal device records

Where to find product info

Model label on device, UDI label, and official recall page linked above

What timeline to expect

Not specified by Sedecal for remediation timelines

If the manufacturer is unresponsive

  • Escalate to hospital risk management or regulatory affairs
  • Report to FDA/recalls portal if applicable
  • Maintain documentation of attempts to contact Sedecal

How to prevent similar issues

  • Follow manual cleaning procedures precisely
  • Do not use water or cleaning agents beyond manual guidance
  • Verify device is within the affected model group before cleaning or servicing
  • Keep a log of all cleaning procedures and contacts

Documentation advice

Photograph labels, serial numbers, UDI, and any communications with Sedecal; retain all recall notices and hospital action plans

Product Details

Model numbers: SM-40HF-B-D-C; 40KW.005. Sold to healthcare facilities in the United States (California, Illinois, New Jersey). Sold from unknown start date. Price not disclosed. Quoted quantity: 6 units. Brand: Sedecal. Serial numbers associated: G64274, G40012, G64597, G70742, G72764, G61804. UDI/DI: 08436046001510.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 6 units recalled
  • Model SM-40HF-B-D-C; 40KW.005
  • Serials: G64274, G40012, G64597, G70742, G72764, G61804
  • UDI/DI: 08436046001510
  • Distribution: US states California, Illinois, New Jersey
  • Hazard: not water-resistant; improper cleaning per manual could cause problems

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
5/ 10
Affected Groups
GENERAL
Injury Types
ELECTRICALOTHER

Product Details

Brand
Model Numbers
SM-40HF-B-D-C; 40KW.005
UDI/DI 08436046001510
G64274
G40012
G64597
+3 more
Affected States
CA, IL, NJ
Report Date
October 29, 2025
Recall Status
ACTIVE

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