Z-0251-2016Class II

Shimadzu C-arm Table, Catalog No. IVS-110, Medical Imaging Table

Name: Z-0251-2016 Shimadzu C-arm Table, Catalog No. IVS-110, Medical Imaging Table
Creator: Shimadzu Medical Systems
Published: 2015-09-30
License: https://open.fda.gov/license/

Shimadzu Medical Systems / initiated 2015-09-30 / Terminated / root cause: software

FDA source

Shimadzu Medical Systems began a recall of Shimadzu C-arm Table, Catalog No. IVS-110, Medical Imaging Table on 2015-09-30. FDA classified it as Class II and gives the reason as "The C-arm may interfere with the table top under certain circumstances". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0251-2016
Classification: Class II
Status: Terminated
Initiated: 2015-09-30
Posted: 2015-11-09
Terminated: 2016-09-12
Recalling firm: Shimadzu Medical Systems
Product: Shimadzu C-arm Table, Catalog No. IVS-110, Medical Imaging Table.
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
Reason for recall: The C-arm may interfere with the table top under certain circumstances.
Root cause tag: software
FDA root cause: Software design
Action: An Urgent Voluntary Medical Device Recall notice was sent on 9/30/2015 to all the customers who purchased the Shimadzu C-arm Table (Catalog No. IVS-110). The notification informs the customers of the description of the issue, the actions to be taken by Shimadzu to correct the issue, and the actions to be taken by the customers. Customers with questions or concerns about the device correction, are instructed to contact their local Shimadzu representative or contact Shimadzu National Technical Support at (800) 228-1429.
Quantity in commerce: 26 units total (4 units in US)
Distribution: Worldwide Distribution. US (Texas, Wisconsin, Ohio, and Connecticut), Iran, India, Saudi Arabia, Serbia, Thailand, Germany, Croatia, Turkey, Lebanon, Korea, and China.
Product codes and lots: Serial Numbers: 0161H25201 0161H25702 0161H25801 0161H28201 0161H27301 0261H26201 0161H29501 0161H29901 0261H26101 0261H26002 0161H25401 0161H29302 0161H26201 0161H27102 0161H25701 0161H26402 0161H26701 0161H29001 0161H26302 0161H25602 0161H26702 0161H28501 0261H25401 0161H28001 0161H27402 0161H27201

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0251-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0251-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-18	2015-11-09

Product code JAA

K963888Class IIC-Arm Table Ivs-100Shimadzu Medical Systems / cleared 1996-12-18

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)