Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported August 9, 2023
Over-Head Ceiling Tube Support, CH-200, CH-200M, Used with RadSpeed and RadSpeed PRO, Sonial Vision safire, Versa and G4 units, FluoroSpeed 300 and X1 units
Eight fixing bolts at the base of the X-ray ceiling tube column assembly may be loose or missing so service is required to install a cable, bracket, and label behind the bracket, …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Shimadzu Corporation Medical Systems Division recalled Over-Head Ceiling Tube Support, CH-200, CH-200M, Used with RadSpeed and RadSpeed PRO, Son… - a moderate-severity action.
Over-Head Ceiling Tube Support, CH-200, CH-200M, Used with RadSpeed and RadSpeed PRO, Son… was recalled by Shimadzu Corporation Medical Systems Division in August 9, 2023. Reason: Eight fixing bolts at the base of the X-ray ceiling tube column assembly may be loose or missing so service i…. Check the official notice for the remedy. Verify recall #Z-2270-2023 with the FDA Devices before acting.
The recall
Shimadzu Corporation Medical Systems Division issued this moderate-severity FDA Devices recall-Eight fixing bolts at the base of the X-ray ceiling tube column assembly may be loose or missing so service i….
- Moderate
- severity level
- 2K units
- affected scope
- Class II
- classification
- August 9, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2270-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2270-2023) was formally reported on August 9, 2023, with the manufacturer initiating the action on April 10, 2023. 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, N/A. Federal records list the affected scope as 1836.
The documented reason for this recall is: Eight fixing bolts at the base of the X-ray ceiling tube column assembly may be loose or missing so service is required to install a cable, bracket, and label behind the bracket, indicating when service is required, to … Distribution data in the federal record shows the product reached: U.S. Nationwide distribution.. 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
1836
Related Recalls
6
3 from same agency
Product description
Over-Head Ceiling Tube Support, CH-200, CH-200M, Used with RadSpeed and RadSpeed PRO, Sonial Vision safire, Versa and G4 units, FluoroSpeed 300 and X1 units
Reason for recall
Eight fixing bolts at the base of the X-ray ceiling tube column assembly may be loose or missing so service is required to install a cable, bracket, and label behind the bracket, indicating when service is required, to eliminate the risk of the device falling.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2270-2023 |
| Date reported | August 9, 2023 |
| Date initiated | April 10, 2023 |
| Recalling firm | Shimadzu Corporation Medical Systems Division |
| Firm location | Kyoto, N/A |
| Affected scope | 1836 |
| Distribution | U.S. Nationwide distribution. |
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-2270-2023) 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? ▼
Over-Head Ceiling Tube Support, CH-200, CH-200M, Used with RadSpeed and RadSpeed PRO, Sonial Vision safire, Versa and G4 units, FluoroSpeed 300 and X1 units. Recalled by Shimadzu Corporation Medical Systems Division. Units affected: 1836.
Why was this product recalled? ▼
Eight fixing bolts at the base of the X-ray ceiling tube column assembly may be loose or missing so service is required to install a cable, bracket, and label behind the bracket, indicating when service is required, to eliminate the risk of the device falling.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 9, 2023. Severity: Moderate. Recall number: Z-2270-2023.
Where was the recalled product distributed? ▼
Distribution: U.S. Nationwide distribution..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2270-2023) 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 August 9, 2023. 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.