HIGH

Sedecal SA Recalls 12 40KWFXPLUS-710CW Mobile X-ray Systems for Cleaning Risk (2025 Recall)

Sedecal SA recalled 12 units of the 40KWFXPLUS-710CW Mobile X-ray system distributed to CA, IL and NJ. The recall cites that the equipment is not water-resistant and must be cleaned strictly per the manual to avoid consequences of improper cleaning. Hospitals and clinics should stop using the device immediately and follow the manufacturer’s recall instructions.

Quick Facts at a Glance

Recall Date
June 10, 2025
Hazard Level
HIGH
AI Risk Assessment
LOW
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 Sedecal SA 40KWFXPLUS-710CW is a mobile X-ray imaging system used in medical facilities for radiographic diagnostics. Such devices are typically mounted on wheels for transport within hospitals.

Why This Is Dangerous

The device is not water-resistant. Cleaning must follow the manual strictly to avoid adverse consequences from improper cleaning, which can compromise safety and performance.

Industry Context

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

Real-World Impact

Hospitals and clinics may need to adjust cleaning procedures and recall communications. The immediate action is to stop use and follow manufacturer instructions to avoid potential equipment damage or patient safety risks.

Practical Guidance

How to identify if yours is affected

  1. 1. Locate model number on the device: 40KWFXPLUS-710CW.
  2. 2. Check associated serial numbers: G83204, G82622, G79677, G79194, G82129, G79632, G79837, G79924, G84490, G84640, G79699, G84605.
  3. 3. Verify UDI: 08436046002166.
  4. 4. Confirm distribution region: CA, IL, NJ in the US.

Where to find product info

Refer to the FDA recall page for details: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0251-2026

What timeline to expect

No timeline is provided for refunds or replacements in the notice. Follow the manufacturer's recall instructions and FDA updates.

If the manufacturer is unresponsive

  • Document all communications with the manufacturer.
  • File a complaint with FDA if manufacturer is unresponsive.
  • Consult hospital risk management for guidance on device removal and replacement options.

How to prevent similar issues

  • Adhere strictly to cleaning instructions in the manual.
  • Do not use water on non-water-resistant devices.
  • Establish a standard cleaning protocol for mobile X-ray systems and train staff accordingly.
  • Verify device specifications before cleaning to avoid inadvertent exposure.

Documentation advice

Keep a copy of the recall notice, list of affected serial numbers, corresponding UDI, and all communications with Sedecal SA for records.

Product Details

Model numbers: 40KWFXPLUS-710CW; UDI/DI 08436046002166; Serial Numbers: G83204, G82622, G79677, G79194, G82129, G79632, G79837, G79924, G84490, G84640, G79699, G84605. Where sold: United States, distributed to California, Illinois, and New Jersey. When sold: Unknown. Price: Unknown.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 12 units recalled
  • Model 40KWFXPLUS-710CW
  • Serials include G83204, G82622, G79677, G79194, G82129, G79632, G79837, G79924, G84490, G84640, G796
  • G84605
  • Not water-resistant
  • Notices sent by email to consignees
View Original Recall on FDA - Medical Devices

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Safety Guide

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Safety Assessment

Risk LevelLOW
Severity Score
1/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeMobile X-ray system
Sold At
Unknown

Product Details

Model Numbers
40KWFXPLUS-710CW
UDI/DI 08436046002166
G83204
G82622
G79677
+9 more
Affected States
CA, IL, NJ
Report Date
October 29, 2025
Recall Status
ACTIVE

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