[pending] Ceiling Type X-Ray Tube Support Models CH-200 and CH-200M used with RADspeed, SonialVision and FLUO
Pending LLM rewrite. Source: FDA_DEVICE Z-0499-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- 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 ex
- Manufacturer
- SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model Numbers: CH-200. UDI code: 04540217014484. Serial Numbers: 3ZC5C2A84014
- 3ZC5C2A85003
- 3ZC5C2A77013
- 3ZC5C2A86013
- 3ZC5C2A75012
- 3ZC5C2A76002
- 3ZC5C2A76016
- 3ZC5C2A76026
- 3ZC5C2A79003
- 3ZC5C2A84008
- 3ZC5C2A73001
- 3ZC5C2A87008
- 3ZC5C2A7A001
- 3ZC5C2A76018
- 3ZC5C2A79001
- 3ZC5C2A7A002
- 3ZC5C2A7B001
- 3ZC5C2A85015
- 3ZC5C2A81001
- 3ZC5C2A86003
Distribution
Distributed nationwide across the United States.
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