Z-0918-2017Class II

Shimadzu X-ray High Voltage Generator Model No. UD150B-40 on SONIALVISION safire II/17 systems with...

Name: Z-0918-2017 Shimadzu X-ray High Voltage Generator Model No. UD150B-40 on SONIALVISION safire II/17 systems with...
Creator: Shimadzu Medical Systems
Published: 2016-11-20
License: https://open.fda.gov/license/

Shimadzu Medical Systems / initiated 2016-11-20 / Terminated

FDA source

Shimadzu Medical Systems began a recall of 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... on 2016-11-20. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0918-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-20
Posted: 2016-12-23
Terminated: 2017-12-11
Recalling firm: Shimadzu Medical Systems
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.
Product code: IZO Generator, High-Voltage, X-Ray, Diagnostic
Reason for recall: 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.
FDA root cause: Under Investigation by firm
Action: The firm, Shimadzu Medical Systems USA, sent an "Urgent Medical Device Recall notice" and Field Safety Notice dated 11/20/16 to customers to inform them that Shimadzu Corporation has identified a potential issue in the Shimadzu X-ray High Voltage Generator UD150B-40. Customers are informed of how to identify the affected products, corrective action plan by Shimadzu, and the actions to be taken by customers. Customers that have not received a call or visit from Shimadzu are instructed to call Shimadzu Medical Systems National Technical Support at (800) 228-1429. Shimadzu sent an updated "URGENT Voluntary Medical Device Recall Notice" letter dated 11/30/16 to its customers on 11/30/16 to inform them that Shimadzu Corp. has identified a potential issue in the Shimadzu X-ray High Voltage Generator UD150B-40 on SONIALVISION safire II/17 systems with 0.7/1.2JG326D X-Ray Tube. The letter informs the customers that when operated for prolonged periods of time at low rate serial exposure, the heat load capacity of the X-ray anode disc (target) may become damaged and leak insulating oil. Customers with questions are instructed to contact Shimadzu National Technical Support at (800) 228-1429.
Quantity in commerce: 13 units
Distribution: US Distribution to states of: AZ, WA, CA, LA, FL, SC, and NJ.
Product codes and lots: Serial No. 3M5249D1C013 3M5249D22013 3M5249D29002 3M5249D2A004 3M5249D2C004 3M5249D31009 3M5249D32012 3M5249D33003 3M5249D34001 3M5249D35002 3M5249D37006 3M5249D41006 3M5249D46003

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0918-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0918-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-04	2016-12-23

Product code IZO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)