Agency classClass IIOur severity:High FDA (Devices)·Z-2270-2023·Announced 2023-08-09

X-Ray Ceiling Tube Support System Recalled Due to Loose Fixing Bolts

Shimadzu ceiling tube supports used with X-ray systems may have loose or missing fixing bolts at the base. The company is providing service to install cables and brackets to prevent the device from falling.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device with identified structural defect risk (loose or missing fixing bolts on ceiling-mounted equipment). Risk-of-harm product where falling equipment could cause serious injury, but no injuries or illnesses have been reported to date.

Plain-English summary

Shimadzu Corporation Medical Systems Division is recalling Over-Head Ceiling Tube Support models CH-200 and CH-200M. These ceiling-mounted tube supports are used with various X-ray and imaging equipment including RadSpeed, Sonial Vision, and FluoroSpeed units. A total of 1,836 units have been distributed nationwide in the United States.

Eight fixing bolts at the base of the X-ray ceiling tube column assembly may be loose or missing. This condition creates a risk that the device could fall, potentially causing injury to staff or patients and damage to equipment in the vicinity.

The recall affects medical facilities that have installed these ceiling tube support systems, particularly those using the specified radiological equipment models. No injuries or accidents have been reported at this time.

Shimadzu is implementing service to address this issue. Affected facilities should contact the company for service that will install a cable, bracket, and label behind the bracket to indicate when service is required. This installation will eliminate the risk of the device falling.

The recalled product

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
Manufacturer: SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Category: Medical Device — X-ray Support System
Hazard: structural-defect
fall-hazard
Affected units: 1,836

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

All manufactured prior to August 1
2019. REF/UDI-DI/Serial Numbers: CH-200/04540217031436/0162M46304
0162M48002
0162M48801
0162M48902
0162M48903
3ZC5C2A21005
3ZC5C2A4B008
3ZC5C2A52005
3ZC5C2A6B011
3ZC5C2A84014
3ZC5C2A85003
3ZC5C2A88019
3ZC5C2A91005
3ZC5C2A92004
0162M46101
0162M46104
0162M47505
0162M47508
0162M48702

Distribution

Distributed nationwide across the United States.

Same manufacturer · SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION

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Same hazard · structural defect