Recall Z-2655-2017— Shimadzu Medical Systems Usa Com
Class II · Terminated
Class II FDA medical device recall by Shimadzu Medical Systems Usa Com, initiated 2017-05-23, terminated 2019-10-01. It names one FDA 510(k) clearance: K152294. Product: 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: Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange..
- Recalling firm
- Shimadzu Medical Systems Usa Com
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-05-23
- Terminated
- 2019-10-01
- Firm location
- Torrance, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.