Recall Z-2499-2018— Philips Healthcare
Class II · Terminated
Class II FDA medical device recall by Philips Healthcare, initiated 2018-06-11, terminated 2024-07-03. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- Philips Healthcare
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-06-11
- Terminated
- 2024-07-03
- Firm location
- Andover, MA, United States
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.