Centron 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.
This recall has been terminated (originally issued June 11, 2018).
- Company
- Philips Healthcare
- Recall Initiated
- June 11, 2018
- Terminated
- July 3, 2024
- Recall Number
- Z-2500-2018
- Quantity
- 459 affected systems
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
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
US Nationwide Distribution
Lot / Code Info
Centron 1.0.10 Centron 1.0.10.1 Centron 1.0.10.5
Root Cause
Software design
Action Taken
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 ensure that all staff with access to the affected systems are informed of the contents of this Field Safety Notice. A copy of this Field Safety Notice shall be placed together with the documentation of the system until the system has been corrected by Philips. For questions contact your local Philips representative Technical Support Line 1-800-722-9377.