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Shimadzu Medical Systems Usa Com Recalls
7 recalls on record · July 5, 2017 to March 27, 2019 · Medical Devices
Recalls by year
17
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19
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
March 27, 2019Medical DevicesFDA
Shimadzu Medical Systems Usa Com recalls SHIMADZU MobileDaRt Evolution (MX8 Version), Mobile X-Ray System Product Usage: This device is intended to be used t
Hazard: In these units, the brake is usually released by gripping the drive handle and applied by letting go of the handle. However, for systems within a specified manufacture period, we have identified that even when letting go of the handle, the systems brakes are not applied. In this event, if the Operator releases the handle when the device is moving, the unit will continue to coast.
March 6, 2019Medical DevicesFDA
Shimadzu Medical Systems Usa Com recalls BRANSIST safire Product Usage: DIGITAL ANGIOGRAPHY SYSTEM This system is intended to be used for radiologic visualiz
Hazard: Normal operation of the device is to power up the device in the morning, register the first patient, and then perform a fluoroscopy. If, however, the user powers up the device in the morning and makes an error by starting a fluoroscopy while the first patient is still being registered, the device application will abnormally terminate and require service intervention before it can be used again. This event will not occur after the first patient procedure.
February 27, 2019Medical DevicesFDA
Shimadzu Medical Systems Usa Com recalls TRINIAS for diagnostic imaging and interventional procedures in cardiac angiography, neurovascular angiography, abdomina
Hazard: Two issues: Event 1: Normal operation of the device is to power up the device in the morning, register the first patient, and then perform a fluoroscopy. If, however, the user powers up the device in the morning and makes an error by starting a fluoroscopy while the first patient is still being registered, the device application will abnormally terminate and require service intervention before it can be used again. This event will not occur after the first patient procedure. Event 2: In rare cases a synchronization error may occur in the data transmission circuit in the device due to external noise. The visibility of the displayed image may be corrupted (images become bit-shifted abnormal images). If this event occurs, it may become difficult to see the object, which may hinder the examination and treatment.
October 31, 2018Medical DevicesFDA
Shimadzu Medical Systems Usa Com recalls TRINIAS Digital Angiographic System intended to be used for cardiac angiography, neurovascular angiography, abdominal an
Hazard: Due to a software issue the C-arm may unexpectedly moved when being moved to the park position and during specific operations. There is a possibility the C-arm will come into contact with a patient or healthcare personnel.
July 5, 2017Medical DevicesFDA
Shimadzu Medical Systems Usa Com recalls SHIMADZU FDR Visionary Catalog Number: FDR Visionary Suite Stationary x-ray system for taking general radiographic an
Hazard: Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange.
July 5, 2017Medical DevicesFDA
Shimadzu Medical Systems Usa Com recalls SHIMADZU RADspeed Pro Catalog Number: RADspeed Pro; Stationary x-ray system
Hazard: Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange.
July 5, 2017Medical DevicesFDA
Shimadzu Medical Systems Usa Com recalls SHIMADZU Ceiling Type X-ray Tube Support CH-200/CH-200M Catalog Number: CH-200/CH-200M Holds an x-ray tube unit and col
Hazard: Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange.