Reported Feb 20, 2019 · Terminated

Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030 Stationary Fluoroscopic X-ray System

Philips Medical Systems GmbH, DMC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Philips Medical Systems Gmbh, DMC · Development And Manufacturing Ctr. · Hamburg, N/A · N/A

Is this the product you have?

  • Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030 Stationary Fluoroscopic X-ray System
Lot codes and dates
  • All CombiDiagnost systems with software version 1.0.0, 1.0.1 and 1.0.2
Amount recalled
146

Where it was sold

Why it was recalled

kV/mA lockin not functioning as specified which may result in the patient receiving an increased radiation dose.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Philips Medical Systems GmbH, DMC recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 2, 2020 · Data as of Sep 19, 4:53 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.