Toshiba American Medical Systems Inc: Medical Device Recall in 2016 - (Recall #: Z-0752-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems

Product Classification:

Class II

Date Initiated: August 14, 2015

Date Posted: February 17, 2016

Recall Number: Z-0752-2016

Event ID: 73078

Reason for Recall:

When a fontal DA (Digital Angiography) acquisition was done, scattered x-ray came into the dose meter on the lateral side. As a result, the dose meter sent a minus value to the software. Consequently, the software defined the data as an "abnormal value" and it stopped displaying dose data and the dose data was lost. The following message was displayed, "Dose meter abnormal, Dose info disabled".

Status: Terminated

Product Quantity: 4

Code Information:

Serial Numbers ACA1492002, AAA1492001, W4B1442020, and W4B1432018.

Distribution Pattern:

US Nationwide Distribution to OH and NY

Voluntary or Mandated:

Voluntary: Firm initiated