HIGH

Sedecal Mobile X-Ray Systems Recalled Over Water Resistance Issues

Sedecal recalled 56 Mobile Digital Diagnostic X-Ray Systems on June 10, 2025. The recall affects the SM-40HF-B-D-KM (AeroDR X30) model due to water resistance concerns. Users must stop using the device immediately and follow cleaning instructions to avoid potential hazards.

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

Product Details

The recall involves Sedecal Mobile Digital Diagnostic X-Ray Systems, model SM-40HF-B-D-KM (AeroDR X30), with serial numbers including G-81478, G81924, and others. These devices were distributed in California, Illinois, and New Jersey.

The Hazard

The manufacturer reminded users that the equipment is not water-resistant. Improper cleaning can lead to malfunction and significant health risks.

Reported Incidents

No specific incidents or injuries have been reported related to this recall, but improper use poses high risks.

What to Do

Stop using the device immediately. Contact SEDECAL SA or your healthcare provider for further instructions and follow the cleaning guidelines provided.

Contact Information

For more information, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0242-2026 or contact SEDECAL SA.

Key Facts

  • Recalled model: SM-40HF-B-D-KM (AeroDR X30)
  • 56 units affected
  • Class II recall
  • Distributed in CA, IL, NJ
  • Contact manufacturer for instructions

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 Digital Diagnostic X-Ray System
Sold At
Multiple Retailers

Product Details

Model Numbers
UDI/DI 08436046002593
Serial Numbers: G-81478
G81924
G84618
G87981
+15 more
Affected States
CA, IL, NJ
Report Date
October 29, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

Related Recalls

HIGH

Novo Nordisk Recalls Wegovy Injection Due to Contamination Risk

Novo Nordisk recalled Wegovy (semaglutide) Injection on December 19, 2025, due to hair found in a prefilled syringe. The recall affects products distributed nationwide in the United States. Consumers should stop using the product immediately and contact their healthcare provider.

Wegovy
Presence of
Read more
HIGH

Zydus Pharmaceuticals Recalls TraZODONE Tablets Over Defects

Zydus Pharmaceuticals recalled over 2,100 bottles of TraZODONE Hydrochloride Tablets on December 19, 2025. Some tablets have surface dents that may affect medication integrity. Consumers should stop using the product immediately and seek guidance from healthcare providers.

Zydus Pharmaceuticals
Failed Tablet/Capsule
Read more
HIGH

Merck Recalls Noxafil Oral Suspension Due to Metal Contamination

Merck Sharp & Dohme LLC recalled 845 kits of Noxafil Powdermix on December 12, 2025. The recall follows the discovery of potential metal particulates in the product. Consumers should stop using the medication immediately and contact their healthcare provider for further guidance.

NOXAFIL
Presence of
Read more
HIGH

Merck Emend Recalled Due to Potential Metal Contamination

Merck Sharp & Dohme LLC recalled 3 single-dose kits of Emend (aprepitant) on December 12, 2025. The recall stems from the potential presence of metal particulates in the medication. Consumers should immediately stop using the product and contact their healthcare provider for guidance.

EMEND
Presence of
Read more
HIGH

Beaver-Visitec Recalls Laser and Endoscopy System Over Safety Hazard

Beaver-Visitec International recalled five units of the OME6000U Laser and Endoscopy System on December 5, 2025. The recall stems from a manufacturing deviation where ferrites required for the USB cable were not installed. This omission poses a high electrical hazard risk to patients and healthcare providers.

Beaver-Visitec International
Manufacturing deviation
Read more