Philips Medical Systems Gmbh, DMC: Medical Device Recall in 2019 - (Recall #: Z-0612-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 7, 2018

Date Posted: February 20, 2019

Recall Number: Z-0612-2019

Event ID: 81706

Reason for Recall:

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

Status: Terminated

Product Quantity: 146

Code Information:

All CombiDiagnost systems with software version 1.0.0, 1.0.1 and 1.0.2

Distribution Pattern:

Worldwide Distribution: US (nationwide) to states of: AZ, CA, GA, IL, MN, MO, MT, NJ, OH, TX, UT & VA; and to countries of: Australia, Austria, Bangladesh, Belgium, Chile C¿te D'Ivoire, Czech Republic. Egypt, Ethiopia, France, Germany, Ghana, Iran, Italy, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Martinique, Mexico, Nepal, Netherlands, New Zealand, Philippines, Portugal Russian Federation, Rwanda, Saudi Arabia, Serbia, South Africa, Spain, Switzerland, Turkey, United Arab Emirates and United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated