Recall archive
8 recalls · page 1 of 1
Reported Oct 29, 2025
Sedecal Mobile Digital Diagnostic X-Ray Systems; SM-40HF-B-D-KM (AeroDR X30)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sedecal Sa
Matched: Brand · Product · Product details · Reason for recall — 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…
45 more products in this recall
FDA (openFDA device enforcement)
Reported May 8, 2024
Battery Mobile X-ray Unit EASY MOVING Model with telescopic column 3.1, model numbers: a. SM-20HF-Batt; b.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sedecal Sa
Matched: Brand — Potential interference with the anti-fall system.
FDA (openFDA device enforcement)
Reported Feb 21, 2024
MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sedecal Sa
Matched: Brand — 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…
FDA (openFDA device enforcement)
Reported Jan 31, 2024
Sedecal X Optima URS digital mobile diagnostic x-ray system. A a stationary x-ray unit with a universal swivel arm. It…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sedecal Sa
Matched: Brand · Product · Product details — Some parts have fallen off the equipment resulting in a safety risk to patients and/or users.
FDA (openFDA device enforcement)
Reported Jul 5, 2023
wDR 2.2 Mobile Digital Diagnostic X-Ray System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sedecal Sa
Matched: Brand — There is a software login in issue that may prevent the user from logging in.
FDA (openFDA device enforcement)
Reported Mar 8, 2023
Phoenix mKDR, digital mobile diagnostic x-ray system
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sedecal Sa
Matched: Brand · Reason for recall — Sedecal was informed of 3 incidents of erratic movements related to X-ray mobile systems.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 16, 2022
Sedecal Soltus Battery Mobile X-Ray System REF Soltus 450 Battery Mobile X-Ray System REF Soltus 500
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sedecal Sa
Matched: Brand · Product · Product details — Due to un-commanded movement of mobile x-ray unit.
FDA (openFDA device enforcement)
Reported Jun 15, 2016
Sedecal SA Mobile Diagnost w DR x-ray system
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sedecal USA, Inc.
Matched: Brand · Product · Product details — Due to a software defect, the system may sporadically apply the default x ray exposure parameters for an adult ( patient type : Normal ) even though…
FDA (openFDA device enforcement)
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