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Terminated

SHIMADZU Ceiling Type X-ray Tube Support CH-200/CH-200M Catalog Number: CH-200/CH-200M Holds an x-ray tube unit and collimator combined with an z-ray high voltage generator, radiographic stand, and table. It is designed to perform radiography of patients either in a standing or supine position

FDA Recall Z-2653-2017 · Posted None

Recalling FirmShimadzu Medical Systems Usa Com
Recall StatusTerminated
Product CodeKPR
Date Initiated2017-05-23
Date Terminated2019-10-01
Product Quantity1673 units total

Reason for Recall

Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange.

Firm Action

Shimadzu sent an Urgent Voluntary Medical Device Recall Notice to all affected customers. The firm will implement a voluntary recall/field corrective action to add protective parts preventing the x-ray tube assembly from coming into contact with the patient or operator should separation of the tube mounting flange from the tube holding shaft occur. Customers with questions were instructed to call 800-228-1429.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution - Nationwide distribution to AK, AR, AZ, CA, CT, FL, IL, IN, KS, LA, MI, MO, NE, NJ, NM, NV, NY,OH, OK, PA, RI, SC, TN, TX, WA, WI, and Hawaii Foreign: Canada and Japan

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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