HIGH

Sedecal SA SM-40HF-B-D-C Mobile X-ray System Recalled for 27 Units in 2025

Sedecal SA recalled 27 SM-40HF-B-D-C mobile X-ray systems distributed in California, Illinois and New Jersey after warning consignees the equipment is not water-resistant and must be cleaned per the manual. The notice outlines possible consequences of improper cleaning. Hospitals and providers should stop using the device immediately and follow recall instructions.

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

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

The SM-40HF-B-D-C is a mobile X-ray system used in clinical imaging. The recall concerns cleaning procedures and water resistance.

Why This Is Dangerous

Improper cleaning or water exposure could lead to safety issues or equipment damage per the manufacturer’s caution.

Industry Context

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

Real-World Impact

Clinicians must halt use until guidance is provided. Hospitals may need to segregate affected units to prevent use and communicate with patients about the recall.

Practical Guidance

How to identify if yours is affected

  1. Verify model SM-40HF-B-D-C
  2. Cross-check serial numbers against Sedecal’s list: G31761, G30761, G32587, G32577, G31065, G33581, G30808, G30762, G29873, G30156, G30173, G30952, G30689, G33004, G30155, G30025, G35450, G35620, G30570
  3. Confirm distribution in CA, IL, NJ

Where to find product info

FDA recall enforcement page and Sedecal’s official communications

What timeline to expect

No timeline provided for remedy; follow instructions in recall notice

If the manufacturer is unresponsive

  • Document all communications with Sedecal SA
  • Escalate to FDA recall contact if needed

How to prevent similar issues

  • Do not clean devices with water or liquids not per manual
  • Train staff on cleaning procedures per the manual
  • Maintain an updated inventory of all mobile X-ray systems and verify recall status before use

Documentation advice

Keep copies of recall notices, serial number lists, and communications with the manufacturer for records

Product Details

Model numbers: SM-40HF-B-D-C Units recalled: 27 Where sold/distributed: United States, CA, IL, NJ Sold to: Consignees (not specified as retail purchasers) Classification: Class II Serial numbers (sample): G31761, G30761, G32587, G32577, G31065, G33581, G30808, G30762, G29873, G30156, G30173, G30952, G30689, G33004, G30155, G30025, G35450, G35620, G30570 Udi/DI: Unknown Price: Unknown

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 27 units recalled
  • Model SM-40HF-B-D-C
  • Serial numbers list includes G31761, G30761, G32587, G32577, G31065, G33581
  • Distributed in CA, IL, NJ (US)
  • Classification: Class II
  • Hazard: not water-resistant; cleaning per manual required
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
OTHER

Product Classification

Product TypeMobile X-ray System
Sold At
Unknown

Product Details

Model Numbers
SM-40HF-B-D-C
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