The Recall Desk
HighFDA (Devices)·Z-0612-2019·Announced 2019-02-20

Philips CombiDiagnost R90 X-ray System Recalled for Radiation Dose Risk

Philips is recalling 146 CombiDiagnost R90 X-ray systems because a software defect may cause patients to receive increased radiation doses.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (increased radiation dose) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.

Plain-English summary

Philips Medical Systems Gmbh, DMC is recalling 146 units of the Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030. The recall affects systems equipped with software versions 1.0.0, 1.0.1, and 1.0.2.

The recall was initiated because the kV/mA lockin function is not operating as specified. This defect may result in patients receiving an increased radiation dose during procedures. The affected units were distributed nationwide in the United States to the states of AZ, CA, GA, IL, MN, MO, MT, NJ, OH, TX, UT, and VA, as well as to numerous countries worldwide.

Healthcare facilities and consumers should contact Philips Medical Systems for further instructions on how to resolve the issue. The source text does not specify a particular action for end-users, but facilities should verify their software version and contact the manufacturer.

The recalled product

Product
Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030 Stationary Fluoroscopic X-ray System
Manufacturer
Philips Medical Systems Gmbh, DMC
Category
Medical Device — Imaging Equipment
Hazard
Affected units
146

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • All CombiDiagnost systems with software version 1.0.0
  • 1.0.1 and 1.0.2

Distribution

Distributed nationwide across the United States.

The notice also names 12 states specifically:

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