The Recall Desk
HighFDA (Devices)·Z-0554-2021·Announced 2020-12-16

Shimadzu Bransist Safire Digital Angiography System Recalled for Software Defect

Shimadzu Medical Systems is recalling seven Bransist Safire Digital Angiography Systems because a software issue could cause the ceiling arm to move unexpectedly, posing a risk of collision or harm.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Shimadzu Medical Systems is recalling seven units of the Bransist Safire Digital Angiography System containing a MS-200 Ceiling Suspended C-arm Support. The recall is due to a problem with the control software for the ceiling arm of the X-Ray System.

The software issue could cause the ceiling arm of the device to move after the operator has released the movement lever. This unexpected movement could result in a possible collision or harm to the patient or the system operator.

The affected units were distributed nationwide in the United States, including in the states of Kentucky, California, Michigan, Ohio, Connecticut, New York, South Carolina, North Carolina, Indiana, Illinois, Tennessee, Louisiana, and Montana. The specific serial numbers for the affected units are 40AD58C55001, 40AD58C4B001, 40AD58C24001, 40AD58522001, 40AD58C1C001, 101X968101, and 091X955901. Healthcare facilities should contact Shimadzu Medical Systems for instructions on how to address the software issue.

The recalled product

Product
Bransist Safire, Digital Angiography System containing a MS-200 Ceiling Suspended C-arm Support - Product Usage: designed to provide fluoroscopic images of the patient during diagnostic surgical and interventional angiography and cardiology procedures.
Manufacturer
Shimadzu Medical Systems
Category
Medical Device — Imaging Equipment
Hazard
Affected units
7

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (7)

  • Serial Numbers: 40AD58C55001
  • 40AD58C4B001
  • 40AD58C24001
  • 40AD58522001
  • 40AD58C1C001
  • 101X968101
  • 091X955901

Distribution

Distributed nationwide across the United States.

The notice also names 13 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Shimadzu Medical Systems under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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