Z-0197-2019 Class II Terminated
FDA device recall Z-0197-2019 was initiated by Shimadzu Medical Systems Usa Com on June 15, 2018 and is designated Class II. 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… The recall status is terminated (terminated April 28, 2021). Affected quantity: 1.
Recall Details
- Product Type
- Devices
- Report Date
- October 31, 2018
- Initiation Date
- June 15, 2018
- Termination Date
- April 28, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1
Product Description
TRINIAS Digital Angiographic System intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures.
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.
Distribution Pattern
Domestic: LA
Code Information
Model Trinias UDI (01)04540217049080(11)170727(21)41E58C977001 Serial Number 41E58C977001