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.
Enforcement
- Recall Number
- Z-2498-2018
- Event ID
- 80402
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Philips Healthcare
- Voluntary / Mandated
- FDA Mandated
- Initial Notification
- Letter
- Report Date
- August 1, 2018
- Initiation Date
- June 11, 2018
- Classification Date
- July 24, 2018
- Termination Date
- July 3, 2024
- Address
- 3000 Minuteman Rd, N/A, Andover, MA, 01810-1032, United States
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.
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.
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
US Nationwide Distribution
459 affected systems