# FDA recall Z-2270-2023

> **SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION** · Class II · device recall initiated 2023-04-10.

## Product

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.

## Distribution

U.S. Nationwide distribution.

## Key facts

- **Recall number:** Z-2270-2023
- **Recalling firm:** SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-04-10
- **Report date:** 2023-08-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Kyoto, N/A, Japan

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2270-2023

## Citation

> AI Analytics. FDA recall Z-2270-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2270-2023. Source: US FDA. Licensed CC0.

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