Company: Toshiba American Medical Systems
Date of Enforcement Report 9/20/2017
Class lI:
PRODUCT
Toshiba Medical Radrex – i Digital Radiography X-ray systemRadrex-i is intended for use in conjunction with the ceiling suspended tube support, high voltage generator, and bucky stand or bucky table incorporating a fixed or detachable (portable) flat panel detector for radiography of the head, chest, abdomen, spine, neck, and limbs.
Recall Number Z-3111-2017
REASON
It was discovered during a procedure that when the operator made an exposure on the wireless x-ray detector and the image data was sent to the digital radiography system, and error message was displayed ” System Error (2063)” which required a reboot and loss of the image.
RECALLING FIRM/MANUFACTURER
Toshiba American Medical Systems, Tustin, CA on 3/23/2017. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
140
DISTRIBUTION
Nationwide
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