Ceiling X-ray tube supports recalled over a shaft that may break
Shimadzu is recalling 1,766 ceiling type X-ray tube supports, models CH-200 and CH-200M, because the mounting shaft may break and the tube assembly could come off.
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: Scored 3 under the risk-of-harm criterion: a shaft that can break and release an overhead tube assembly is a fall hazard, and no injuries are reported.
Plain-English summary
Ceiling Type X-Ray Tube Supports, models CH-200 and CH-200M, used with RADspeed, SonialVision and FLUOROspeed systems, are being recalled. The support holds the X-ray tube and collimator and positions the tube unit.
The recall follows a potential breakage issue with the shaft for the mounting of the X-ray tube assembly, which could result in the assembly coming off the rotating shaft.
The recall covers 1,766 devices carrying UDI code 04540217014484, distributed worldwide including nationwide in the United States. The FDA has classified the action as Class II.
A tube assembly detaching from an overhead support is a fall hazard to anyone beneath it. The enforcement record reports no injuries. Sites operating an affected support should follow Shimadzu's instructions.
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 — X-ray system
- Affected units
- 1,766
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
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