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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Shimadzu CH-200 and CH-200M X-Ray Tube Supports Recalled for Shaft Breakage

Agency Publication Date: November 13, 2025
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Summary

SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION is recalling approximately 1,766 units of its Ceiling Type X-Ray Tube Support Models CH-200 and CH-200M. These components are used in RADspeed, SonialVision, and FLUOROspeed imaging systems to hold and position X-ray tubes. The recall was initiated because the mounting shaft for the X-ray tube assembly can break, which could cause the entire assembly to detach and fall from the rotating shaft. This equipment is used worldwide for whole-body radiographic examinations.

Risk

If the mounting shaft breaks, the X-ray tube assembly could fall unexpectedly. This poses a serious risk of impact injury to patients or medical staff who may be positioned beneath the equipment during a medical examination.

What You Should Do

  1. This recall affects Shimadzu Ceiling Type X-Ray Tube Support Models CH-200 and CH-200M used with RADspeed, SonialVision, and FLUOROspeed Systems.
  2. To determine if your equipment is affected, check the model and serial numbers located on the device label. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled medical device immediately to prevent potential injury from equipment failure.
  4. Contact Shimadzu Corporation or your authorized distributor to arrange for a return, replacement, or on-site correction of the mounting shaft.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 for additional questions regarding medical device recalls.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Ceiling Type X-Ray Tube Support CH-200
Variants: RADspeed System component, SonialVision System component, FLUOROspeed System component
Model / REF:
CH-200
Serial Numbers (1484):
3ZC5C2A84014
3ZC5C2A85003
3ZC5C2A77013
3ZC5C2A86013
3ZC5C2A75012
3ZC5C2A76002
3ZC5C2A76016
3ZC5C2A76026
3ZC5C2A79003
3ZC5C2A84008
3ZC5C2A73001
3ZC5C2A87008
3ZC5C2A7A001
3ZC5C2A76018
3ZC5C2A79001
3ZC5C2A7A002
3ZC5C2A7B001
3ZC5C2A85015
3ZC5C2A81001
3ZC5C2A86003
3ZC5C2A7C007
3ZC5C2A84002
3ZC5C2A7B019
3ZC5C2A77010
3ZC5C2A73006
3ZC5C2A74004
3ZC5C2A75002
3ZC5C2A75005
3ZC5C2A75006
3ZC5C2A75007
3ZC5C2A76010
3ZC5C2A76013
3ZC5C2A76022
3ZC5C2A77011
3ZC5C2A77012
3ZC5C2A77014
3ZC5C2A77023
3ZC5C2A78002
3ZC5C2A78003
3ZC5C2A79002
3ZC5C2A7C006
3ZC5C2A7C016
3ZC5C2A82004
3ZC5C2A83002
3ZC5C2A85010
3ZC5C2A85016
3ZC5C2A85018
3ZC5C2A86002
3ZC5C2A86009
3ZC5C2A86011
UDI:
04540217014484

Used with RADspeed, SonialVision and FLUOROspeed Systems.

Product: Ceiling Type X-Ray Tube Support CH-200M
Variants: RADspeed System component, SonialVision System component, FLUOROspeed System component
Model / REF:
CH-200M
Serial Numbers (282):
41E733E74005
41E733E72003
41E733E85002
41E733E86001
41E733E86002
41E733E86003
41E733E86004
41E733E88001
41E733E72001
41E733E72002
41E733E72005
41E733E74001
41E733E74003
41E733E74004
41E733E85001
41E733E88002
41E733E88003
41E733E72004
41E733E86005
41E733E74002
41E733E88004
0262M42603
0362M44102
0462M43402
0462M43403
0562M43907
0362M44701
41E733E67002
41E733E64004
41E733E65001
41E733E63005
3ZC5C1661001
41E733E64001
41E733E6B004
0462M40101
3ZC5C160C005
0662M41305
0562M42808
3ZC5C1653001
3ZC5C1652002
0662M40807
0662M40806
0662M40401
0362M44502
0462M43404
3ZC5C1632004
0262M40510
3ZC5C1617001
0462M45001
0462M45003
UDI:
04540217050826

Used with RADspeed, SonialVision and FLUOROspeed Systems.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97365
Status: Active
Manufacturer: SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Sold By: Medical equipment distributors; Authorized hospital supply networks
Manufactured In: Japan
Units Affected: 1,766 devices
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.