Recall Z-2653-2017— 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. FDA's recall record names no specific 510(k) clearance for this event. Product: 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. 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
Product description
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
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.