HIGH

Sedecal SM-40HF-B-D-C 40KW Mobile X-ray System Recall 2025

Sedecal SA recalled 4 units of the SM-40HF-B-D-C 40KW Mobile X-ray System distributed to U.S. facilities in California, Illinois and New Jersey. The equipment is not water-resistant and must be cleaned strictly according to the manual. Facilities 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
Brand
Sedecal SA
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

Get instant alerts for Health & Personal Care recalls

Be the first to know. Free instant alerts to your inbox.

No spamUnsubscribe anytime

About This Product

This is a mobile X-ray imaging system used in hospitals and clinics to perform radiographs at point of care.

Why This Is Dangerous

Not water-resistant. Cleaning must follow the manual. Improper cleaning could affect device integrity or performance.

Industry Context

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

Real-World Impact

Facilities must stop using the device immediately. Without a remedy timeline, there may be imaging delays and operational disruption.

Practical Guidance

How to identify if yours is affected

  1. Confirm model SM-40HF-B-D-C and verify UDI 08436046001510
  2. Check serial numbers G35611, G37536, G37588, G37490
  3. Confirm recall status on FDA page Z-0270-2026
  4. Review cleaning procedures in the operator manual

Where to find product info

FDA enforcement page for recall Z-0270-2026 and Sedecal notices

What timeline to expect

Remedy timeline not specified; expect updates from Sedecal and FDA within weeks to months

If the manufacturer is unresponsive

  • Document all inquiries to Sedecal SA
  • Escalate to FDA recall contacts if no response within 2-4 weeks
  • Consider medical device regulatory counsel if needed

How to prevent similar issues

  • Always follow the manual cleaning procedures for equipment
  • Ensure water exposure is avoided on non-water-resistant devices
  • Verify device specifications before cleaning or servicing
  • Select replacement devices with clear water-resistance and cleaning protocols

Documentation advice

Keep the recall notification, record model/UDI/serial numbers, document communications with Sedecal SA or providers

Product Details

Model numbers: SM-40HF-B-D-C Description: 40KW 55C/60C Mobile X-ray system Sold in: United States, CA IL NJ When sold: Unknown Price: Unknown

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 4 units recalled
  • Model SM-40HF-B-D-C
  • Not water-resistant; cleaning per manual required
  • Distribution: CA, IL, NJ
  • Recall date: 2025-06-10
  • Status: Active (Z-0270-2026) at FDA
View Original Recall on FDA - Medical Devices

Browse More Recalls

More from FDA_DEVICEHealth & Personal CareMedical Devices

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

Get Alerts for Health & Personal Care Recalls

Get instant alerts for recalls that affect you. Free forever.

Safety Assessment

Risk LevelHIGH
Severity Score
7/ 10
Affected Groups
GENERAL
Injury Types
ELECTRICAL

Product Classification

Product TypeMobile X-ray System
Sold At
Multiple Retailers

Product Details

Model Numbers
SM-40HF-B-D-C
UDI/DI 08436046001510
G35611
G37536
G37588
+1 more
Affected States
CA, IL, NJ
Report Date
October 29, 2025
Recall Status
ACTIVE

Related Recalls

Health & Personal Care
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.

Sedecal SA
Sedecal sent
Read more
Health & Personal Care
HIGH

Sedecal SA Recalled 5 SM-40HF-B-D-C Mobile X-ray Systems for Cleaning Warning (2025)

Sedecal SA recalled 5 SM-40HF-B-D-C 40KW 55G Mobile X-ray systems distributed in the US (CA, IL, NJ) after warning that the equipment is not water-resistant and must be cleaned strictly per the manual. The notice outlines the possible consequences of improper cleaning. Healthcare facilities should stop using the devices immediately and contact Sedecal SA for instructions.

Sedecal SA
Sedecal sent
Read more
Health & Personal Care
HIGH

Sedecal SA Recalls 9 SM-40HF-Batt Mobile X-ray Systems (2025)

Sedecal SA is recalling 9 units of the SM-40HF-Batt 40KW analog Mobile X-ray System distributed in California, Illinois and New Jersey. The company sent an email to consignees warning the equipment is not water-resistant and must be cleaned strictly per the manual. Improper cleaning could cause system damage. Hospitals and clinics should stop using the devices immediately and contact Sedecal SA or

Sedecal SA
Sedecal sent
Read more
Health & Personal Care
HIGH

Sedecal SA Recalls 17 SM_40HF_B_D_VIR3 Mobile X-ray Systems Over Water-Resistance Cleaning Risk (202

Sedecal SA recalled 17 SM_40HF_B_D_VIR3 Mobile X-ray systems distributed in California, Illinois and New Jersey after emailing consignees that the equipment is not water-resistant and must be cleaned exactly as the manual directs. The notices warn about consequences of improper cleaning. Hospitals and clinics should stop using the device and follow the recall instructions from Sedecal SA or their

Sedecal SA
Sedecal sent
Read more
Health & Personal Care
HIGH

Sedecal SA Recalls 4 SM-40HF-B-D-C Mobile X-ray Systems in 2025

Sedecal SA recalled 4 SM-40HF-B-D-C 40KW mobile X-ray systems sold in California, Illinois and New Jersey. A notice warns the equipment is not water-resistant and must be cleaned exactly as described in the manual to avoid possible consequences of improper cleaning. Healthcare providers should stop using the device immediately and contact Sedecal SA or their provider for instructions.

Sedecal SA
Sedecal sent
Read more
Health & Personal Care
HIGH

Sedecal SA Recalls Shimadzu RF.004 Mobile X-ray System in 2025

Sedecal SA is recalling the Shimadzu RF.004 Mobile X-ray System after warnings that the device is not water-resistant and must be cleaned strictly according to the manual. Hospitals in California, Illinois, and New Jersey are affected. Stop using the device and follow recall instructions.

Sedecal SA
Sedecal sent
Read more
Health & Personal Care
HIGH

Sedecal SA Recalls 22 SM-32HF-Batt Mobile X-ray Systems for Cleaning Risk (2025)

Sedecal SA recalled 22 SM-32HF-Batt 32KW analog mobile X-ray systems distributed to California, Illinois and New Jersey. The units are not water-resistant and must be cleaned strictly per the manual, with explicit consequences for improper cleaning. Healthcare facilities should stop using the devices immediately and follow the manufacturer's recall instructions sent by email.

Sedecal SA
Sedecal sent
Read more