Philips CombiDiagnost R90 Fluoroscopy Device May Display Wrong Patient Images
The Philips CombiDiagnost R90 fluoroscopy device may display a previous patient's radiography images during an examination, risking privacy violation and diagnostic errors in 86 affected units.
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: This is a risk-of-harm medical device (FDA Class II) capable of displaying previous patients' medical images, creating patient privacy and diagnostic confusion risks. No illnesses or injuries have been reported, meeting the rubric criterion for high-severity recalls of risk-of-harm products where injury has not yet occurred.
Plain-English summary
Philips Medical Systems is recalling the CombiDiagnost R90 1.0 (Model 709030) fluoroscopy imaging system because the Radio Fluoroscopy (RF) viewer can display a previous patient's radiography images during a fluoroscopy examination. When this occurs, the displayed images differ in content, format, and size from the current examination's images.
Eighty-six units have been distributed across the United States, including in California, Florida, Georgia, Illinois, Indiana, Kansas, Maryland, Maine, Michigan, Minnesota, North Carolina, New Jersey, New York, Texas, Virginia, and Washington. This condition creates risks related to patient privacy and potential diagnostic confusion if the incorrect images are used in clinical evaluation.
The recalled product
- Product
- CombiDiagnost R90 1.0 (709030)
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Hazard
- image-display-error
- patient-data-exposure
- misdiagnosis-risk
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 1.0 (709030)
- UDI DI: 00884838076747
- Software version 1.1.1 or higher
- Serial numbers: 10000000
- 10000002
- 10000003
- 10000004
- 10000006
- 10000011
- 10000012
- 10000020
- 10000024
- 10000027
- 10000049
- 10000050
- 10000065
- 10000066
- 10000067
- 10000069
- 10000078
Distribution
Distributed nationwide across the United States.
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