Class II U.S. Food and Drug Administration

Shimadzu Corporation Medical Systems Division Ceiling Type X-Ray Tube Support Models recall: Due to an issue (potential breakage) with the shaft for the mounting

Recall published 11 months ago

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 hazard: Device safety concern

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

What the notice says: 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.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-0499-2026
Published
November 19, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Shimadzu Corporation Medical Systems Division
Product type
Medical devices
Units affected
1,766 devices
Distribution
Nationwide
Made in
Japan
Lot / code info
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, 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, 3ZC5C2A87010, 3ZC5C2A88003, 3ZC5C2A88005, 3ZC5C2A81002, 3ZC5C2A85017, 3ZC5C2A7B002, 3ZC5C2A86004, 3ZC5C2A85005, 3ZC5C2A71003, 3ZC5C2A86010, 3ZC5C2A81004, 3ZC5C2A73012, 3ZC5C2A73013, 3ZC5C2A73014, 3ZC5C2A76006, 3ZC5C2A76019, 3ZC5C2A76027, 3ZC5C2A77003, 3ZC5C2A7B015, 3ZC5C2A85019, 3ZC5C2A88008, 3ZC5C2A77002, 3ZC5C2A85002, 3ZC5C2A85001, 3ZC5C2A74005, 3ZC5C2A72005, 3ZC5C2A73002, 3ZC5C2A73009, 3ZC5C2A73010, 3ZC5C2A74007, 3ZC5C2A76008, 3ZC5C2A76009, 3ZC5C2A76017, 3ZC5C2A77001, 3ZC5C2A77009, 3ZC5C2A77017, 3ZC5C2A78005, 3ZC5C2A78006, 3ZC5C2A79007, 3ZC5C2A7B008, 3ZC5C2A7B011, 3ZC5C2A7B016, 3ZC5C2A7C014, 3ZC5C2A7C017, 3ZC5C2A81005, 3ZC5C2A81006, 3ZC5C2A81014, 3ZC5C2A84009, 3ZC5C2A85011, 3ZC5C2A85013, 3ZC5C2A75008, 3ZC5C2A85009, 3ZC5C2A7B009, 3ZC5C2A76001, 3ZC5C2A7C009, 3ZC5C2A7C010, 3ZC5C2A87009, 3ZC5C2A7C005, 3ZC5C2A7B013, 3ZC5C2A7B014, 3ZC5C2A73003, 3ZC5C2A77005, 3ZC5C2A74006, 3ZC5C2A81007, 3ZC5C2A75003, 3ZC5C2A72002, 3ZC5C2A72003, 3ZC5C2A72004, 3ZC5C2A72006, 3ZC5C2A73011, 3ZC5C2A74002, 3ZC5C2A75004, 3ZC5C2A76007, 3ZC5C2A76014, 3ZC5C2A76015, 3ZC5C2A77007, 3ZC5C2A77008, 3ZC5C2A77015, 3ZC5C2A77016, 3ZC5C2A77019, 3ZC5C2A77022, 3ZC5C2A79004, 3ZC5C2A7B006, 3ZC5C2A7B012, 3ZC5C2A7B018, 3ZC5C2A7C008, 3ZC5C2A81008, 3ZC5C2A82001, 3ZC5C2A84010, 3ZC5C2A84011, 3ZC5C2A85006, 3ZC5C2A85007, 3ZC5C2A86007, 3ZC5C2A87007, 3ZC5C2A88002, 3ZC5C2A88006, 3ZC5C2A87011, 3ZC5C2A87012, 3ZC5C2A86012, 3ZC5C2A77004, 3ZC5C2A7B003, 3ZC5C2A74008, 3ZC5C2A75001, 3ZC5C2A76011, 3ZC5C2A77021, 3ZC5C2A7B004, 3ZC5C2A7B007, 3ZC5C2A7B010, 3ZC5C2A7C015, 3ZC5C2A85012, 3ZC5C2A86005, 3ZC5C2A87002, 3ZC5C2A87003, 3ZC5C2A76024, 3ZC5C2A77018, 3ZC5C2A79006, 3ZC5C2A81003, 3ZC5C2A82002, 3ZC5C2A86008, 3ZC5C2A87013, 3ZC5C2A88001, 3ZC5C2A77020, 3ZC5C2A83001, 3ZC5C2A85004, 3ZC5C2A85008, 3ZC5C2A73005, 3ZC5C2A78004, 3ZC5C2A79005, 3ZC5C2A7B017, 3ZC5C2A7C001, 3ZC5C2A82003, 3ZC5C2A83004, 3ZC5C2A84001, 3ZC5C2A74010, 3ZC5C2A72001, 3ZC5C2A73004, 3ZC5C2A73008, 3ZC5C2A87005, 3ZC5C2A76004, 3ZC5C2A76025, 3ZC5C2A7A003, 3ZC5C2A7C004, 3ZC5C2A7C011, 3ZC5C2A81011, 3ZC5C2A81013, 3ZC5C2A84003, 3ZC5C2A74001, 3ZC5C2A87004, 3ZC5C2A87006, 3ZC5C2A88004, 3ZC5C2A88007, 3ZC5C2A74003, 3ZC5C2A75010, 3ZC5C2A75011, 3ZC5C2A76003, 3ZC5C2A76005, 3ZC5C2A76012, 3ZC5C2A76020, 3ZC5C2A78001, 3ZC5C2A7C003, 3ZC5C2A81010, 3ZC5C2A84005, 3ZC5C2A84012, 3ZC5C2A71002, 3ZC5C2A71004, 3ZC5C2A73007, 3ZC5C2A74009, 3ZC5C2A76023, 3ZC5C2A7C002, 3ZC5C2A73015, , Model Numbers: CH-200, UDI codes: N/A, Serial Numbers:, 0162M46304, 0162M47002, 0162M48002, 0162M48801, 0162M48902, 0162M48903, 3ZC5C2A21005, 3ZC5C2A4B008, 3ZC5C2A52005, 3ZC5C2A6B011, 0162M46101, 0162M46104, 0162M47505, 0162M47508, 0162M48702, 0162M49006, 0162M49203, 0162M49501, 0162M50007, 0262M49709, 0262M46103, 3ZC5C2A41006, 0362M46501, 0262M48307, 0362M46710, 0362M48206, 0362M49902, 0462M45303, 0462M48001, 0462M48209, 0462M48302, 0462M48902, 3ZC5C2A16003, 3ZC5C2A21006, 3ZC5C2A23017, 3ZC5C2A23019, 3ZC5C2A28011, 3ZC5C2A31002, 3ZC5C2A32006, 3ZC5C2A34003, 3ZC5C2A35018, 3ZC5C2A38016, 3ZC5C2A39004, 3ZC5C2A39005, 3ZC5C2A3A009, 3ZC5C2A3C010, 3ZC5C2A41001, 3ZC5C2A41002, 3ZC5C2A41003, 3ZC5C2A44006, 3ZC5C2A46006, 3ZC5C2A46007, 3ZC5C2A4C009, 3ZC5C2A53011, 3ZC5C2A53013, 3ZC5C2A5C008, 3ZC5C2A5C009, 3ZC5C2A62003, 3ZC5C2A62004, 3ZC5C2A62008, 3ZC5C2A630…

Products covered by this recall

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.

Check your product

The notice names 4 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Model or item number

On the rating label, the box or the instruction sheet.

  • CH-200

Serial number

On the rating plate, often next to the date of manufacture.

  • 3ZC5C2A84014
  • 3ZC5C2A85003
  • 3ZC5C2A77013

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Shimadzu Corporation Medical Systems Division — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If you are a facility, quarantine affected stock and log the correction.
  3. Report device problems to the FDA through MedWatch.
  4. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

Company contact: SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION — Nishinokyo Kuwabara -Cho, Kyoto

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Shimadzu Corporation Medical Systems Division medical… recalled?

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. 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.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: model number CH-200. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Where was the recalled product sold?

It was distributed nationwide.

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