HIGH

Sedecal SA Recalled 1 Mobile X-ray System 40KWFXPLUS.889 in 2025 for Cleaning Not Water-Resistant

Sedecal SA recalled 1 unit of the Mobile X-ray System 40KWFXPLUS.889 distributed in California, Illinois and New Jersey. The recall concerns cleaning practices and the device not being water-resistant. Hospitals and clinics should stop using the device immediately and follow recall instructions. Contact Sedecal SA for instructions via the recall notice distributed by email.

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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About This Product

The Mobile X-ray System is used in clinical settings for radiographic imaging. It is a specialized medical device that helps diagnose and monitor patients.

Why This Is Dangerous

The device is not water-resistant and must be cleaned strictly according to the manual. Improper cleaning could lead to unintended consequences as outlined by the manufacturer.

Industry Context

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

Real-World Impact

The immediate impact is operational disruption for facilities using the device. There is a potential safety risk if cleaning is not performed per protocol, but no injuries are reported in the recall notice.

Practical Guidance

How to identify if yours is affected

  1. 1) Locate the device label on the system for model numbers.
  2. 2) Verify model 40KWFXPLUS.889.
  3. 3) Check serial number G77146 and UDI/DI 08436046002166.

Where to find product info

Recall details are provided via email by Sedecal SA and are available in the FDA enforcement report Z-0250-2026.

What timeline to expect

There is no specific timeline provided for remedy processing beyond the recall notice.

If the manufacturer is unresponsive

  • Escalate to hospital or facility administration.
  • Contact Sedecal SA for documentation and follow-up.
  • If issues remain unresolved, consider filing a complaint with the appropriate regulatory agency.

How to prevent similar issues

  • Always follow the cleaning instructions in the manual.
  • Do not expose non-water resistant devices to cleaning agents or processes not approved in the manual.
  • Establish a protocol for handling recalls and ensure staff are trained on follow-up actions.

Documentation advice

Save the recall notice email, device label, serial numbers, and any correspondence with the manufacturer or healthcare provider.

Product Details

Model: 40KWFXPLUS.889; UDI/DI: 08436046002166; Serial Number: G77146. Distribution: United States, states CA, IL, NJ. Recall Date: 2025-06-10. Status: ACTIVE. Price: Unknown.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 1 unit recalled
  • Model 40KWFXPLUS.889
  • UDI/DI 08436046002166
  • Serial number G77146
  • Distribution: CA, IL, NJ (USA)
  • Recall date 2025-06-10
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
7/ 10
Affected Groups
GENERAL
Injury Types
ELECTRICALOTHER

Product Classification

Product TypeMobile X-ray System
Sold At
Unknown

Product Details

Model Numbers
40KWFXPLUS.889
UDI/DI 08436046002166
G77146
Affected States
CA, IL, NJ
Report Date
October 29, 2025
Recall Status
ACTIVE

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