The Recall Desk
HighFDA (Devices)·Z-0555-2021·Announced 2020-12-16

Shimadzu Trinias Digital Angiography System Recalled for Ceiling Arm Software Issue

Shimadzu is recalling 23 Trinias Digital Angiography Systems because a software defect may cause the ceiling arm to move unexpectedly, posing a risk of collision or harm to patients and operators.

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 23 units of the Trinias Digital Angiography System, which includes the MH-200 Ceiling Suspended C-arm Support. The recall is due to a problem identified in the control software for the ceiling arm of the X-Ray System.

The software issue could cause the ceiling arm 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 devices were distributed nationwide in the United States, including in Kentucky, California, Michigan, Ohio, Connecticut, New York, South Carolina, North Carolina, Indiana, Illinois, Tennessee, Louisiana, and Montana.

Facilities with these devices should contact Shimadzu Medical Systems for instructions on how to resolve the issue. The recall affects specific serial numbers listed in the official FDA record Z-0555-2021.

The recalled product

Product
Trinias, Digital Angiography System containing a MH-200, Ceiling Suspended C-arm Support - Product Usage: intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and w
Manufacturer
Shimadzu Medical Systems
Category
Medical Device — Imaging Equipment
Hazard
Affected units
23

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 (20)

  • Affected Serial Numbers: 41EFCD7A6001 41EFC73A5001
  • 41EFCD79C001
  • 41EFD3B9C001
  • 41EFFF79C001
  • 41EFD3B9A001
  • 41EFCD79A001
  • 41EFFF79A001
  • 41F005B91001
  • 41F005B8C001
  • 41EFCD78B001
  • 41EFCD77C001
  • 41E58C776001
  • 41E58C777001
  • 41E58C775001
  • 41E58C773001
  • 41E58C76B001
  • 41E58C769001
  • 41E58C766001
  • 41E58C765001
  • 41E58C757001

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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