FDA recall Z-2500-2018

Philips Healthcare · Class II · device

Product

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.

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

Key facts

Status
Terminated
Initiation date
2018-06-11
Report date
2018-08-01
Termination date
2024-07-03
Voluntary/Mandated
FDA Mandated
Location
Andover, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2500-2018