Sedecal recalls
7 official recalls and safety alerts involving Sedecal since 2022-11, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Sedecal or the relevant agency.
- 2025-10-29
USSEDECAL SA recalls MobileDiagnost wDR 2.2; Model Number REF 9890-010-89522, Mobile X-ray system
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…
- 2024-05-08
- US
SEDECAL SA recalls Battery 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;…
Potential interference with the anti-fall system.
FDA · DeviceSEDECAL SAWorldwide distribution - US Nationwide in the states of CA, IL, NJ, and areas…Official notice → - 2024-02-21
- US
SEDECAL SA recalls MobileDiagnost 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…
FDA · DeviceSEDECAL SAUS Nationwide distribution. There was government distribution but no military…Official notice → - 2024-01-31
- US
SEDECAL SA recalls Sedecal 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…
Some parts have fallen off the equipment resulting in a safety risk to patients and/or users.
FDA · DeviceSEDECAL SADistribution was made to AL, FL, and NC. There was no military/government…Official notice → - 2023-07-05
- US
SEDECAL SA recalls wDR 2.2 Mobile Digital Diagnostic X-Ray System
There is a software login in issue that may prevent the user from logging in.
FDA · DeviceSEDECAL SADistribution throughout United States including Puerto Rico and US Virgin…Official notice → - 2023-03-08
- US
SEDECAL SA recalls Phoenix mKDR Xpress, digital mobile diagnostic x-ray system
Sedecal was informed of 3 incidents of erratic movements related to X-ray mobile systems.
- 2022-11-16
- US
SEDECAL SA recalls Sedecal Soltus Battery Mobile X-Ray System REF Soltus 450 Battery Mobile X-Ray System REF Soltus 500
Due to un-commanded movement of mobile x-ray unit.
FDA · DeviceSEDECAL SAU.S.: KY, WI, FL, DE, WV, CA, MO, NY, NC, AL, AR, MS, GA, IL, IA, TN, KS, KY,…Official notice →