Device product
UNIQ Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and minimally invasive procedures. Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA,stent placing,atherectomies), pacemaker implantat ions, and electrophysiology (EP). Non-vascular interventions such as drainages,biopsies and vertebroplasties procedures.
Z-2499-2018
Product summary
- Event
- Event 80402
- Status
- Terminated
- Classification
- Class II
- Quantity
- 459 affected systems
- Official record key
device-enforcement:Z-2499-2018
Official wording
Reason: The first time an operator selects a new procedure type during a single examination,the shutter position resets to the open position for the new procedure type. If the shutters had previously been changed during the examination, that setting is not retained after the first time the procedure type is changed during a single examination.
Code information: UNIQ 1.0.10 UNIQ 1.0.10.5
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
The first time an operator selects a new procedure type during a single examination,the shutter position resets to the open position for the new procedure type. If the shutters had previously been changed during the examination, that setting is not retained after the first time the procedure type is changed during a single examination.