FDAClass IIJanuary 4, 2017

Shimadzu X-ray High Voltage Generator recall

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…

Why was Shimadzu X-ray High Voltage Generator recalled?

Shimadzu Medical Systems is recalling the Shimadzu X-ray High Voltage Generator due to the possibility of oil leaking from the x-ray tube housing under certain conditions.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Serial No. 3M5249D1C013 3M5249D22013 3M5249D29002 3M5249D2A004 3M5249D2C004 3M5249D31009 3M5249D32012 3M5249D33003 3M5249D34001 3M5249D35002 3M5249D37006 3M5249D41006 3M5249D46003

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…
Recalling firm
Shimadzu Medical Systems
Quantity
13 units
Distribution
US Distribution to states of: AZ, WA, CA, LA, FL, SC, and NJ.
Recall date
January 4, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls