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U.S. Department of Health and Human Services

Class 2 Device Recall Toshiba Infinix Solid state xray imager (flat panel/digital imager)

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  Class 2 Device Recall Toshiba Infinix Solid state xray imager (flat panel/digital imager) see related information
Date Initiated by Firm May 12, 2014
Date Posted June 04, 2014
Recall Status1 Terminated 3 on October 02, 2014
Recall Number Z-1714-2014
Recall Event ID 68363
510(K)Number K120073  
Product Classification Solid state x-ray imager - Product Code MQB
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.
Code Information Serial Numbers: ULD1412014, UUC13Z2011, A4A113Z2001.
Recalling Firm/
Manufacturer
Toshiba American Medical Systems Inc
2441 Michelle Dr
P.O. Box 2068
Tustin CA 92780-7047
For Additional Information Contact Don L. Fowler
714-730-5000
Manufacturer 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.
FDA Determined
Cause 2
Other
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.
Quantity in Commerce 2
Distribution Nationwide Distribution including CA and IN
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MQB and Original Applicant = TOSHIBA MEDICAL SYSTEMS CORPORATION
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