The Recall Desk
HighFDA (Devices)·Z-1585-2016·Announced 2016-05-04

Shimadzu X-Ray Diagnostic Table Recalled for Unintentional Reverse Tilting

Shimadzu Medical Systems is recalling 185 X-Ray Diagnostic Tables (Model YSF-300) due to reports of unintentional movement to reverse tilting.

What this means for you

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: The recall is classified as FDA Class II. The hazard involves unintentional movement of a medical device, which poses a risk of harm to patients or operators, but the source does not report specific injuries or fatalities, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Shimadzu Medical Systems is recalling 185 units of the X-Ray Diagnostic Table, Model No. YSF-300. The recall was initiated due to reports of unintentional movement of the table to reverse tilting. This table is used in combination with an X-ray high voltage generator, an X-ray tube unit, an image intensifier, and an X-ray television unit for X-ray T.V. fluoroscopy, spot-filming, and Bucky radiography.

The affected units were distributed nationwide. The recall covers specific serial numbers listed in the official FDA record. No specific dates of manufacture or distribution are provided in the source text.

Consumers and healthcare facilities should contact Shimadzu Medical Systems for further instructions on how to address the defect. The FDA has classified this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
X-Ray Diagnostic Table, Model No. YSF-300 Use in combination with an X-ray high voltage generator, an X-ray tube unit, an Image intensifier and X-ray television unit, this table is applied for the following X-ray examinations: -X-ray T.V. fluoroscopy -Spot-filming -Bucky radiogr
Manufacturer
Shimadzu Medical Systems
Category
Medical Device — Diagnostic Imaging
Hazard
Affected units
185

Distribution

Distributed nationwide across the United States.

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