FDA Device Recall Z-0012-2018: Toshiba American Medical Systems Inc

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0012-2018.

Recall Res Number

Z-0012-2018

Recalling Firm / Manufacturer

Toshiba American Medical Systems Inc

FEI Number

2020563

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2017-09-12

Date Posted

N/A

Date Terminated

2020-11-18

Product Code

JAA

Event Number

78166

Product Quantity

US - 96

Product Description Toshiba Medical Kalare Fluoroscopic X-Ray System (DREX-KL80) Kalare is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations. It is intended for use by qualified/trained doctors or technologists on both adult and pediatric subjects taking radiographic and fluoroscopic exposures of the whole body, skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing or lying in prone or supine positions.

Reason for Recall During an examination images were displayed on the live monitor,but the images were not displayed on the system monitor nor were they saved to the hard disk.

Action Details Toshiba planned action to bring defect into compliance: 1. You will issue a Customer Notification Letter to make customers aware of the hazards, what measures will be taken to remedy the defect at no cost to the user, and how to safely use the equipment before corrections can be made. 2. You will install modified firmware on the systems to correct the defect and prevent recurrence. 3. You will provide progress reports on the effectiveness of the plan. CDRH approves the CAP subject to the following conditions: 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator are to be included in the notification. Thank you for your urgent attention to this matter. If you have any questions regarding this letter please feel free to call (800) 421-1968, or contact your local Toshiba Representative at (800) 521-1968. For further questions please call (714) 730-5000.

Distribution Pattern USA (nationwide) Distribution

Code Information / Serial Numbers Model: HDR-08A

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Medical Device Recall: Z-0012-2018

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer