Reported Nov 19, 2025 · Ongoing
Ceiling Type X-Ray Tube Support Models CH-200 and CH-200M used with RADspeed, SonialVision and FLUOROspeed Systems The…
Shimadzu Corporation Medical Systems Division
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION · Nishinokyo Kuwabara -Cho · Kyoto · N/A
Is this the product you have?
- 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.
- Lot codes and dates
- Model NumbersCH-200
- UDI code04540217014484
- Serial Numbers
220 of 220 codes
3ZC5C2A840143ZC5C2A850033ZC5C2A770133ZC5C2A860133ZC5C2A750123ZC5C2A760023ZC5C2A760163ZC5C2A760263ZC5C2A790033ZC5C2A840083ZC5C2A730013ZC5C2A870083ZC5C2A7A0013ZC5C2A760183ZC5C2A790013ZC5C2A7A0023ZC5C2A7B0013ZC5C2A850153ZC5C2A810013ZC5C2A860033ZC5C2A7C0073ZC5C2A840023ZC5C2A7B0193ZC5C2A770103ZC5C2A730063ZC5C2A740043ZC5C2A750023ZC5C2A750053ZC5C2A750063ZC5C2A750073ZC5C2A760103ZC5C2A760133ZC5C2A760223ZC5C2A770113ZC5C2A770123ZC5C2A770143ZC5C2A770233ZC5C2A780023ZC5C2A780033ZC5C2A790023ZC5C2A7C0063ZC5C2A7C0163ZC5C2A820043ZC5C2A830023ZC5C2A850103ZC5C2A850163ZC5C2A850183ZC5C2A860023ZC5C2A860093ZC5C2A860113ZC5C2A870103ZC5C2A880033ZC5C2A880053ZC5C2A810023ZC5C2A850173ZC5C2A7B0023ZC5C2A860043ZC5C2A850053ZC5C2A710033ZC5C2A86010
- Model NumbersCH-200
- UDI codesN/A
- Serial Numbers
1,264 of 1,264 codes
0162M463040162M470020162M480020162M488010162M489020162M489033ZC5C2A210053ZC5C2A4B0083ZC5C2A520053ZC5C2A6B0110162M461010162M461040162M475050162M475080162M487020162M490060162M492030162M495010162M500070262M497090262M461033ZC5C2A410060362M465010262M483070362M467100362M482060362M499020462M453030462M480010462M482090462M483020462M489023ZC5C2A160033ZC5C2A210063ZC5C2A230173ZC5C2A230193ZC5C2A280113ZC5C2A310023ZC5C2A320063ZC5C2A340033ZC5C2A350183ZC5C2A380163ZC5C2A390043ZC5C2A390053ZC5C2A3A0093ZC5C2A3C0103ZC5C2A410013ZC5C2A410023ZC5C2A410033ZC5C2A440063ZC5C2A460063ZC5C2A460073ZC5C2A4C0093ZC5C2A530113ZC5C2A530133ZC5C2A5C0083ZC5C2A5C0093ZC5C2A620033ZC5C2A620043ZC5C2A62008
- Model NumbersCH-200M
- UDI codes04540217050826
- Serial Numbers
41E733E7400541E733E7200341E733E8500241E733E8600141E733E8600241E733E8600341E733E8600441E733E8800141E733E7200141E733E7200241E733E7200541E733E7400141E733E7400341E733E7400441E733E8500141E733E8800241E733E8800341E733E7200441E733E8600541E733E7400241E733E88004
- Model NumbersCH-200M
- UDI codesN/A
- Serial Numbers
261 of 261 codes
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
- Amount recalled
- 1,766 devices
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Shimadzu Corporation Medical Systems Division recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.