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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- 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
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