Recall Z-2499-2018 ยท OWB Interventional Fluoroscopic X-Ray System
Philips Healthcare
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 drai
| Date | Jun 11, 2018 |
| Status | Terminated |
| 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. |
| Root cause | Software design |
| Action | An Urgent Medical Device Correction letter dated June 11, 2018 was sent to customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers, until a software revision that corrects this issue becomes available, users should verify that the desired shutter position is set when performing the run after the first time the procedure type is changed during a single examination. This can be accomplished by first selecting a different procedure and then reselect the original procedure on the Xper Module or on the Data Monitor. Customer shall e |
| Quantity | 459 affected systems |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.