Shimadzu Medical Systems Usa Com: Medical Device Recall in 2019 - (Recall #: Z-0959-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

BRANSIST safire Product Usage: DIGITAL ANGIOGRAPHY SYSTEM This system is intended to be used for radiologic visualization of the heart, blood vessels or lymphatic system during or after injection of a contrast medium. It is to be used in the diagnosis of the circulatory vascular system while being combined with a positioning device and other devices.

Product Classification:

Class II

Date Initiated: January 14, 2019

Date Posted: March 6, 2019

Recall Number: Z-0959-2019

Event ID: 81981

Reason for Recall:

Normal operation of the device is to power up the device in the morning, register the first patient, and then perform a fluoroscopy. If, however, the user powers up the device in the morning and makes an error by starting a fluoroscopy while the first patient is still being registered, the device application will abnormally terminate and require service intervention before it can be used again. This event will not occur after the first patient procedure.

Status: Terminated

Product Quantity: 8 units

Code Information:

Serial Numbers: 40AD58C4B001, 40AD58C55001, 0261Q80503, 0261Q80804, 0161Q84501, 0161Q83102, 3M7A16A1A001, 0161Q82302

Distribution Pattern:

US Nationwide Distribution in the states of IN, OH, IL, SC

Voluntary or Mandated:

Voluntary: Firm initiated