SEDECAL SA Recalls

24 recalls found for SEDECAL SA. Check if any of your products are affected.

Health & Personal Care
HIGH
FDA DEVICE

Sedecal SA Recalls 1 SM-40HF-B-D-C Mobile X-ray System in 2025

Sedecal SA recalled 1 unit of SM-40HF-B-D-C 40KW 55C Mobile X-ray System distributed to CA, IL and NJ. The recall notice warns the device is not water-resistant and must be cleaned strictly per the manual, with explicit consequences for improper cleaning. Facilities and healthcare providers should stop using the device immediately and follow the recall instructions. Notification was sent by email.

Sedecal SA
Sedecal sent
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Health & Personal Care
HIGH
FDA DEVICE

Sedecal SM-40HF-B-D-C 40KW Mobile X-ray System Recalled for Cleaning Water-Resistance Issue (2025)

Sedecal SA recalled 39 mobile X-ray systems due to a cleaning instruction issue that could cause improper maintenance. The recall affects units in the US and Canada. An email to consignees emphasizes the device is not water-resistant and must be cleaned per the manual, outlining potential consequences of improper cleaning. Healthcare facilities should stop using the device immediately and followSE

Sedecal SA
Sedecal sent
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Health & Personal Care
HIGH
FDA DEVICE

Sedecal SA Recalls 14 SM-40HF-B-D-C Mobile X-ray Systems for Cleaning Not Water-Resistant Risk (2025

Sedecal SA recalled 14 SM-40HF-B-D-C mobile X-ray systems distributed in California, Illinois and New Jersey after notifying consignees by email that the devices are not water-resistant. The company says cleaning must follow the manual strictly, warning about possible consequences of improper cleaning. Healthcare facilities and patients should stop using the devices immediately and follow the REMS

SEDECAL SA
Sedecal sent
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Health & Personal Care
HIGH
FDA DEVICE

SEDECAL SA 40KWFXPLUS Mobile X-ray System Recall 268 Units in 2025

SEDECAL SA recalled 268 units of the 40KWFXPLUS Mobile X-ray System distributed in California, Illinois and New Jersey. The device is not water-resistant and must be cleaned strictly according to the manual. Healthcare facilities should stop using the device immediately and await further recall instructions.

SEDECAL SA
Sedecal sent
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