Z-2655-2017 Class II Terminated
FDA device recall Z-2655-2017 was initiated by Shimadzu Medical Systems Usa Com on May 23, 2017 and is designated Class II. Reason for recall: Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange. The recall status is terminated (terminated October 1, 2019). Affected quantity: 1673 units total.
Recall Details
- Product Type
- Devices
- Report Date
- July 5, 2017
- Initiation Date
- May 23, 2017
- Termination Date
- October 1, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1673 units total
Product Description
SHIMADZU FDR Visionary Catalog Number: FDR Visionary Suite Stationary x-ray system for taking general radiographic and tomographic images of the whole body. The device is intended to be used in hospitals, clinics, imaging centers, and/or other healthcare facilities by qualified/trained professionals
Reason for Recall
Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange.
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
Code Information
Serial No. 0162M4501 thru 0562M45103, 3ZC5C2A0C002 thru 3ZC5C1734001, D362M42902 thru 0562M41101, 41E733E69003, MP95A8F5A001 thru MP95A9F6B001