Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported November 19, 2025
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 di
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.
Shimadzu Corporation Medical Systems Division recalled Ceiling Type X-Ray Tube Support Models CH-200 and CH-200M used with RADspeed, SonialVisi… - a moderate-severity action.
Ceiling Type X-Ray Tube Support Models CH-200 and CH-200M used with RADspeed, SonialVisi… was recalled by Shimadzu Corporation Medical Systems Division in November 19, 2025. Reason: Due to an issue (potential breakage) with the shaft for the mounting of the X-ray tube assembly that could po…. Check the official notice for the remedy. Verify recall #Z-0499-2026 with the FDA Devices before acting.
The recall
Shimadzu Corporation Medical Systems Division issued this moderate-severity FDA Devices recall-Due to an issue (potential breakage) with the shaft for the mounting of the X-ray tube assembly that could po….
- Moderate
- severity level
- 2K units
- affected scope
- Class II
- classification
- November 19, 2025
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0499-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0499-2026) was formally reported on November 19, 2025, with the manufacturer initiating the action on October 16, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. Shimadzu Corporation Medical Systems Division is listed as the recalling firm, operating out of Kyoto. Federal records list the affected scope as 1,766 devices.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR,…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
1,766 devices
Related Recalls
6
3 from same agency
Product description
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.
Reason for recall
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0499-2026 |
| Date reported | November 19, 2025 |
| Date initiated | October 16, 2025 |
| Recalling firm | Shimadzu Corporation Medical Systems Division |
| Firm location | Kyoto |
| Affected scope | 1,766 devices |
| Distribution | Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SM, SC, SD, TN,… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0499-2026) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Shimadzu Corporation Medical Systems Division. Units affected: 1,766 devices.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 19, 2025. Severity: Moderate. Recall number: Z-0499-2026.
Where was the recalled product distributed? ▼
Distribution: Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SM, SC, SD, TN, TX, VA, WA, and WI. The countries of Dominica, Grand Bahama, Haiti, and Saint Maarten..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0499-2026) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported November 19, 2025. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.