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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