SEDECAL SA
5 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for SEDECAL SA and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-10-29FDA-DeviceClass IISedecal Mobile Digital Diagnostic X-Ray Systems; SM-40HF-B-D-KM (AeroDR X30)
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.
- 2024-05-08FDA-DeviceClass IIBattery Mobile X-ray Unit EASY MOVING Model with telescopic column 3.1, model numbers: a. SM-20HF-Batt; b. SM-32HF-Batt; c. SM-40HF-Batt; d. SM-50HF-Batt; e. SM-40-HF-B-D-VIR; f. SM-20HF-B-D-KM (AeroDR X30); g. SM-32-HF-B-D-KM (AeroDR X30); h. SM-40HF-B-D-KM (AeroDR X30); i. SM-50HF-B-D-KM (AeroDR X30); j. MobileDiagnost wDR.
Potential interference with the anti-fall system.
- 2024-02-21FDA-DeviceClass IIMobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007
While cleaning or disinfecting the system, if the process is not followed as described in the manual and excessive liquid is used or sprayed directly on the system, it could cause a short circuit of the fine positioning control button. This would result in the system moving on its own in a very slow speed forward circular motion.
- 2024-01-31FDA-DeviceClass IISedecal X Optima URS digital mobile diagnostic x-ray system. A a stationary x-ray unit with a universal swivel arm. It allows one to take exposures of patients in standing, sitting, or laying position.
Some parts have fallen off the equipment resulting in a safety risk to patients and/or users.
- 2023-07-05FDA-DeviceClass IIwDR 2.2 Mobile Digital Diagnostic X-Ray System
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