The Recall Desk
HighFDA (Devices)·Z-1088-2024·Announced 2024-02-21

Philips CombiDiagnost R90 Fluoroscopy Display May Show Previous Patient Images

Philips CombiDiagnost R90 fluoroscopy systems may display a previous patient's images during radiography examination, potentially showing different image content, format, and size that could affect imaging accuracy.

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: FDA Class II medical device with potential for diagnostic error due to display of previous patient's radiography images, but no injuries or illnesses have been reported. This is a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Philips Medical Systems is recalling the CombiDiagnost R90 1.1 fluoroscopy system due to a display malfunction that may occur during radiography examinations.

The device's Radio Fluoroscopy viewer may inadvertently display radiography images from a previous patient examination. If this occurs, the displayed images will have different content, format, and size compared to the current patient's images. This could potentially lead to confusion during clinical assessment.

Approximately 130 units have been distributed nationwide to facilities in California, Florida, Georgia, Illinois, Indiana, Kansas, Maryland, Maine, Michigan, Minnesota, North Carolina, New Jersey, New York, Texas, Virginia, and Washington.

Healthcare providers who operate affected CombiDiagnost R90 1.1 systems should contact Philips Medical Systems for guidance on remediation or device replacement options. Verify your equipment's serial number and software version against the affected units list provided by the manufacturer.

The recalled product

Product
CombiDiagnost R90 1.1 (709031)
Manufacturer
PHILIPS MEDICAL SYSTEMS
Category
Medical Device — Fluoroscopy System
Hazard
Affected units
130

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 (20)

  • Model: R90 1.1 (709031)
  • UDI DI: 00884838101456
  • Software version 1.1.1 or higher
  • Serial Numbers: 10001004
  • 10001005
  • 10001006
  • 10001008
  • 10001009
  • 10001010
  • 10001011
  • 10001012
  • 10001013
  • 10001018
  • 10001020
  • 10001022
  • 10001024
  • 10001026
  • 10001027
  • 10001028
  • 10001029

Distribution

Distributed nationwide across the United States.

The notice also names 16 states specifically:

Part of a larger recall action

This product is one of 2 recalled by PHILIPS MEDICAL SYSTEMS under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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Same hazard · display malfunction

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