Class 2 Device Recall INFX8000F Fluoroscopic XRay Systems

• Date Initiated by Firm: December 29, 2017
• Create Date: March 02, 2018
• Recall Status: Terminated on November 29, 2023
• Recall Number: Z-0842-2018
• Recall Event ID: 79153
• 510(K)Number: K081624
• Product Classification: Peripheral electromagnetic field (pemf) to aid wound healing - Product Code MBQ
• Product: INFX-8000F Fluoroscopic X-Ray Systems
• Code Information: Serial Numbers: AHA1592004, AGB1482001, AHA1482001, AGA1492002, AHA14Z2002, AGA1552003, UUB13Y2039, AHA15Y2005, AHA1612006, AHB1662007, AGB1682004, AGB1692005, AGB16Z2006, AHB1712008, AHB1712009, AGB1712007, AHA1582003
• FEI Number: 2020563
• Recalling Firm/ Manufacturer: Toshiba American Medical Systems Inc; PO Box 2068; 2441 Michelle Dr; Tustin CA 92780-7047
• For Additional Information Contact: 714-730-5000
• Manufacturer Reason for Recall: During an examination a device error occurred and the ceiling drive operation was disabled. It was found that the fastening bolts of the driving portion of the ceiling drive loosened cause the error.
• FDA Determined Cause: Process control
• Action: A recall notification letter was sent to affected consignees on 12/29/2017. The following information was included in the notification letter: Should this problem occur prior to the above corrective action and in the middle of a clinical case, you will be able continue the case tentatively. The x-ray emissions will be still available and the inhibited ceiling support device can be overridden by pressing the override switch on the left side of the operation console. If any abnormalities are found during use, please stop using your system and contact your Toshiba service representative. Please share this information with all users and reviewing radiologist as well as clinical engineering and the biomedical group at your facility.
• Quantity in Commerce: 17 units
• Distribution: United States
• 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 = MBQ