Z-2498-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 1, 2018
- Initiation Date
- June 11, 2018
- Termination Date
- July 3, 2024
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 459 affected systems
Product Description
Allura Xper 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.
Reason for Recall
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.
Distribution Pattern
US Nationwide Distribution
Code Information
Allura 8.1.25 Allura 8.1.25.1 Allura 8.1.25.5 Allura 8.2.25 Allura 8.2.25.5 Allura 8.2.27