Medical Imaging Software Bug May Cause Incorrect X-ray Exposure
Philips CombiDiagnost R90 imaging software has a bug where exposure settings may change unexpectedly, resulting in over or under-exposed X-ray images. About 66 systems in the US are affected.
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: This is an FDA Class II recall of a diagnostic medical device with a software defect that poses a risk of harm through incorrect image quality and exposure control, but no reported illnesses or injuries to date.
Plain-English summary
Philips Medical Systems is recalling the CombiDiagnost R90 radiographic imaging system (software versions R1.0 and R1.1, model 706100) due to a software bug affecting X-ray exposure control.
The bug occurs when the collimator shutter position is changed immediately after the Lock-In command. When this happens, the kV (kilovoltage) and mA (milliamperage) values—which control X-ray exposure intensity—do not remain locked as intended and may change unexpectedly. This results in X-ray images that are either over-exposed or under-exposed, potentially compromising diagnostic image quality.
Approximately 66 systems are affected in the United States. The recall applies to all units running software versions R1.0 and R1.1. Customers and healthcare facilities using this equipment should contact Philips for a software update or corrective instructions.
The recalled product
- Product
- CombiDiagnost R90 Software Version R1.0 and R1.1
- Manufacturer
- Philips Medical Systems Gmbh, DMC
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 (1)
- Model 706100
Distribution
Distributed nationwide across the United States.
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