Recall Z-0499-2026— SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Class II · Ongoing
Class II FDA medical device recall by SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION, initiated 2025-10-16. FDA's recall record names no specific 510(k) clearance for this event. Product: Ceiling Type X-Ray Tube Support Models CH-200 and CH-200M used with RADspeed, SonialVision and FLUOROspeed Systems The ceiling type x-ray tube support CH-200 is used to hold the X-ray tube and collimator to position the X-ray tube unit. This unit is used for radiographic examinations of whole body except mammography when combined with an X-ray high voltage generator, an X-ray tube unit, an X-ray collimator, and if necessary, an X-ray radiography stand, an X-ray radiography table, and digital radiography system.. Reason: Due to an issue (potential breakage) with the shaft for the mounting of the X-ray tube assembly that could potentially result assembly coming off the rotating shaft..
- Recalling firm
- SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-10-16
- Firm location
- Kyoto, Japan
Product description
Ceiling Type X-Ray Tube Support Models CH-200 and CH-200M used with RADspeed, SonialVision and FLUOROspeed Systems The ceiling type x-ray tube support CH-200 is used to hold the X-ray tube and collimator to position the X-ray tube unit. This unit is used for radiographic examinations of whole body except mammography when combined with an X-ray high voltage generator, an X-ray tube unit, an X-ray collimator, and if necessary, an X-ray radiography stand, an X-ray radiography table, and digital radiography system.
Reason for recall
Due to an issue (potential breakage) with the shaft for the mounting of the X-ray tube assembly that could potentially result assembly coming off the rotating shaft.
Data sourced from openFDA. This site is unofficial and independent of the FDA.