Toshiba American Medical Systems Inc

Entity profile compiled from public source records

Public Record Profile Registrations: 0 510(k) filings: 0 Recalls: 9

Known Identifiers & Locations

FEI Numbers 2020563
Owner Operator Numbers N/A
Locations Covered N/A

Registered Establishments (0)

No device registration and listing records found for this entity.

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (9)

Recall # Product Description Initiation Date Status Action
Z-0005-2009 Toshiba Infinix fluoroscopy DFP-8000D Digital Radiography System with version 3.40 or higher software. Controller for Infinix interventional angiography systems. Reason: Audible signal is not available at all times when using the HLC fluoroscopy mode. Special means of activation are not designed in for selection of High Level Controls, as required by regulation. 2008-09-29 Terminated View Details
Z-0005-2016 Celesteion PCA-9000A/2 PET/CT System Reason: It was found that if specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved due to a software problem. 2015-05-08 Terminated View Details
Z-0012-2018 Toshiba Medical Kalare Fluoroscopic X-Ray System (DREX-KL80) Kalare is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations. It is intended for use by qualified/trained doctors or technologists on both adult and pediatric subjects taking radiographic and fluoroscopic exposures of the whole body, skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing or lying in prone or supine positions. Reason: During an examination images were displayed on the live monitor,but the images were not displayed on the system monitor nor were they saved to the hard disk. 2017-09-12 Terminated View Details
Z-0013-2016 Toshiba Aquilion CT System TSX-101A Reason: If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved. 2015-05-08 Terminated View Details
Z-0014-2016 Toshiba Aquilion CT System TSX-301A Reason: If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved. 2015-05-08 Terminated View Details
Z-0015-2016 Toshiba Aquilion CT System TSX-301B Reason: If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved. 2015-05-08 Terminated View Details
Z-0016-2016 Toshiba Aquilion CT System TSX-301C Reason: If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved. 2015-05-08 Terminated View Details
Z-0017-2016 Toshiba Aquilion CT System TSX-302A Reason: If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved. 2015-05-08 Terminated View Details
Z-0018-2016 Toshiba Aquilion CT System TSX-303A Reason: If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved. 2015-05-08 Terminated View Details

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