TRINIAS Digital Angiographic System intended to be used for cardiac angiography, neurovascular angiography, abdominal an

FDA device recall Z-0197-2019 · posted 2018-10-19 · Terminated

Recall details

Recalling firm

Shimadzu Medical Systems Usa Com

Reason for recall

Due to a software issue the C-arm may unexpectedly moved when being moved to the park position and during specific operations. There is a possibility the C-arm will come into contact with a patient or healthcare personnel.

Action taken

On June 15, 2018, the firm sent an URGENT Voluntary Medical Device Recall Notice to its customer via certified mail informing the customer that the Trinias C-arm could unexpectedly move while being moved to the park position and/or when performing specific operations. An investigation has shown that a software defect in the MH300, which is a floormount C-arm tube support of the Trinias biplane system, caused this event under specific conditions described as below. Neither the Trinias single plane system nor the Trinias dual plane system have the software defect. If the incident were to recur, there is a possibility the C-arm will come into contact with a patient or healthcare personnel. The specific conditions are as follows: (1) The table top is positioned at head side so that the C-arm safety interlock is active. (2) If operator performs a parking operation and presses a direct memory switch at the same time, the the software runs abnormally, and the C-arm does not movebecause the safety interlock is active (1). (3) If the operator then moves the table top to foot side, the C-arm safety interlock is cancelled. (4) While the C-arm safety interlock is cancelled due to the actions performed in (3), the C-arm starts moving without the operators control. Therefore, the firm will implement a voluntary recall/field corrective action to revise the software, thereby fixing the problem. This Field Safety Notice is intended to inform the customer about: - the description of the issue - the actions planned by Shimadzu to correct the issue - the actions that should be taken by the customer How to identify the affected products: The Shimadzu Digital Angiographic System Trinias; Serial Number 41E58C977001 Please contact the local Shimadzu representative or contact Shimadzu National Technical Support. Corrective action plan by Shimadzu: After the software defect has been corrected and the correction safety and efficacy have been verified through our verifi

Root cause

Software design

Status

Terminated

Product code

OWB

Quantity affected

1

Distribution

Domestic: LA

Date initiated

2018-06-15

Date posted

2018-10-19

Date terminated

2021-04-28

Location

Torrance, CA

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