Z-0555-2021 Class II Ongoing
FDA device recall Z-0555-2021 was initiated by Shimadzu Medical Systems on November 18, 2020 and is designated Class II. Reason for recall: The firm has identified a problem with the control software for the celling arm of the X-Ray System . This software issue could cause the ceiling arm of the device to move after the operator has rel… The recall status is ongoing. Affected quantity: 23 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 16, 2020
- Initiation Date
- November 18, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 23 units
Product Description
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 whole body radiographic/fluoroscopic procedures.
Reason for Recall
The firm has identified a problem with the control software for the celling arm of the X-Ray System . This software issue could cause the ceiling arm of the device to move after the operator has released the movement lever. This could result in possible collision or harm to the patient or system operator.
Distribution Pattern
US Nationwide distribution including in the states of KY, CA, MI, OH, CT, MI, NY, SC, NC,IN, IL, TN, LA, CT, MT.
Code Information
Affected Serial Numbers: 41EFCD7A6001 41EFC73A5001, 41EFCD79C001, 41EFD3B9C001, 41EFFF79C001, 41EFD3B9A001, 41EFCD79A001, 41EFFF79A001, 41F005B91001, 41F005B8C001, 41EFCD78B001, 41EFCD77C001, 41E58C776001, 41E58C777001, 41E58C775001, 41E58C773001, 41E58C76B001, 41E58C769001, 41E58C766001, 41E58C765001, 41E58C757001, 41B24774C001, 41B247746001,