HIGH

SEDECAL Recalls Mobile X-ray System Due to Water Resistance Issue

SEDECAL SA recalled 181 units of its Mobile X-ray system on June 10, 2025. The recall warns users that the equipment is not water-resistant and requires strict cleaning protocols. Improper cleaning may lead to serious consequences for patients and healthcare providers.

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

Product Details

The recalled product is the Mobile X-ray system, Model Number SM-40HF-B-D-C; 40KW 70C. It was distributed in California, Illinois, and New Jersey.

The Hazard

The Mobile X-ray system is not water-resistant, which poses a risk of electrical hazards if improperly cleaned. Users must adhere strictly to the cleaning instructions provided in the manual.

Reported Incidents

There have been no reported injuries or incidents associated with this recall. All users are advised to follow the manufacturer's cleaning instructions to prevent any potential hazards.

What to Do

Stop using the Mobile X-ray system immediately. Contact SEDECAL SA or your healthcare provider for further instructions regarding the recall.

Contact Information

For further information, visit SEDECAL's website or contact them directly. The recall notification was sent via email to consignees.

Key Facts

  • Recall date: June 10, 2025
  • Status: ACTIVE
  • Quantity recalled: 181 units
  • Distribution: CA, IL, NJ

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Safety Assessment

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

Product Classification

Product Details

Model Numbers
SM-40HF-B-D-C
UDI/DI 08436046001510
D11-40KW-F
G36689
G37293
+16 more
Affected States
CA, IL, NJ
Report Date
October 29, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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