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
Reported: August 9, 2023 Initiated: April 10, 2023 #Z-2270-2023
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.
Details
- Recalling Firm
- SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
- Units Affected
- 1836
- Distribution
- U.S. Nationwide distribution.
- Location
- Kyoto, N/A
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.
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