Sedecal S.A Recalls
4 recalls on record · February 11, 2015 to November 28, 2018 · Medical Devices
Recalls by year
15
16
18
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
Also filed under
The recall feeds record what looks like the same company under more than one name:
November 28, 2018Medical DevicesFDA
Sedecal S.A. recalls Sedecal NOVA FA DR System. for diagnostic radiography.
Hazard: A safety problem with installation and maintenance could lead to the breakage of the two steel cables that support the equipment to its roof anchor. Due to this, the equipment may fall and cause harm to the patient, user, or third parties.
March 16, 2016Medical DevicesFDA
Sedecal S.A. recalls Mobile wDR motorized portable diagnostic X-ray systems. Intended for use by a qualified/trained doctor or technologist
Hazard: This is related to previous 806 Notifications about uncommanded movements of a motorized mobile x-ray system. Reason for Recall: Along with the previously noted encoder and gauges problems and corresponding fixes, we have observed that static electricity can also elicit the unwanted behavior.
August 26, 2015Medical DevicesFDA
Sedecal S.A. recalls RadPro 40kW Digital X-Ray Panel and Mobile/Portable Diagnostic X-Ray. Intended for use by a qualified/trained doctor
Hazard: Electrostatic energy may be stored in Systems that can cause a short-cicuit which, in turn, can generate an Electomagnetic Pulse which might disturb the electronics of the Digital Motion Control Board producing uncontrolled movements and such uncontrolled movements could cause the system to bump into the user or ppatient.
February 11, 2015Medical DevicesFDA
Sedecal S.A. recalls MobileDiagnost wDR motorized portable diagnostic X-ray systems.
Hazard: Reports of unexpected movement.