The Recall Desk
HighFDA (Devices)·Z-0918-2017·Announced 2017-01-04

Shimadzu X-ray High Voltage Generator Recalled for Oil Leak Risk

Shimadzu Medical Systems is recalling 13 X-ray high voltage generators due to a potential oil leak from the x-ray tube housing.

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 involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Shimadzu Medical Systems is recalling 13 units of the Shimadzu X-ray High Voltage Generator Model No. UD150B-40. These units are installed on SONIALVISION safire II/17 systems equipped with 0.7/1.2JG326D X-Ray Tubes.

The recall is being conducted because of the possibility of oil leaking from the x-ray tube housing under certain conditions. The affected units were distributed in the United States to the states of Arizona, Washington, California, Louisiana, Florida, South Carolina, and New Jersey.

Specific serial numbers for the recalled units are listed in the official recall documentation. Healthcare facilities and users of these diagnostic systems should contact Shimadzu Medical Systems for further instructions regarding the recall and necessary corrective actions.

The recalled product

Product
Shimadzu X-ray High Voltage Generator Model No. UD150B-40 on SONIALVISION safire II/17 systems with 0.7/1.2JG326D X-Ray Tube Diagnostic x-ray high voltage generator.
Manufacturer
Shimadzu Medical Systems
Category
Medical Device — Diagnostic Imaging
Hazard
Affected units
13

Distribution

Distributed in 7 states:

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