11
Jun
2014

Cl II Toshiba Infinix X-Ray

0

Company: Toshiba American Medical Systems Inc
Date of Enforcement Report:6/11/2014
Class lI:

PRODUCT

Toshiba Infinix X-Ray Interventional System INFX-8000V/UU. An X-Ray system that is capable of radiographic and fluoroscopic studies used in an interventional setting.
Recall Number Z-1714-2014

REASON
Toshiba America Medical Systems, Inc. initiated a recall of Toshiba Infinix X-Ray (INFX-8000V/UU), because it has been found that although the Flat Panel Detector (FPD) touch sensor is activated during use, the error message is displayed and the audible signal continues sounding during the table movement of longitudinal tilt, and does not stop..

RECALLING FIRM/MANUFACTURER
Toshiba American Medical Systems Inc, Tustin, CA on 4/12/2014 Voluntary: Firm Initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
2

DISTRIBUTION
Nationwide

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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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