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.
FDA Recall Z-1714-2014 · Posted 2014-06-04
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Recalling FirmToshiba American Medical Systems Inc
Recall StatusTerminated
Product CodeMQB
Date Initiated2014-05-12
Date Terminated2014-10-02
Product Quantity2
Reason for Recall
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, the movement of longitudinal tilt does not stop.
Firm Action
Toshiba America Medical Systems, Inc. initiated this recall by sending recall notifications via USPS return receipt mail.
The recall notification letter, dated May 12, 2014, titled "URGENT: MEDICAL DEVICE CORRECTION", informed customers of the following: device information, serial number, SID, reason for reason, purpose of the notification, corrective action, request to customers, contact information, and customer reply form.
Customers with questions regarding this letter were instructed to call (800) 421-1968 or contact their local Toshiba Representative at (800) 521-1968.
For questions regarding this recall call 714-730-5000.
Root Cause
Other
Distribution Pattern
Nationwide Distribution including CA and IN
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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