# FDA recall Z-2500-2018

> **Philips Healthcare** · Class II · device recall initiated 2018-06-11.

## 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

- **Recall number:** Z-2500-2018
- **Recalling firm:** Philips Healthcare
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-2500-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-2500-2018. Source: US FDA. Licensed CC0.

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