FDA Device recall Z-2500-2018
Centron Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and minimally in…
- FDA Device
- Class II
- terminated
- Published 2018-08-01
On 2018-08-01 the FDA classified a Class II recall of Centron Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and minimally in… by Philips Healthcare, citing 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 ha….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2500-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-06-11 |
| Published | 2018-08-01 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Healthcare |
| Distribution | US |
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
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.
Identifiers
| code_info | Centron 1.0.10 Centron 1.0.10.1 Centron 1.0.10.5 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2500-2018%22
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