Philips ProxiDiagnost N90 X-ray System Recalled for Software Lock-in Defect
Philips is recalling 91 ProxiDiagnost N90 X-ray systems because kV and mA values may not lock correctly after a command, potentially affecting image quality.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a software defect without reporting any injuries, illnesses, or deaths. Per the rubric, this fits the 'Moderate' category for low-risk issues or voluntary precautionary recalls where harm has not been reported.
Plain-English summary
Philips Home Healthcare Solutions is recalling 91 units of the ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system. The recall is due to a software defect where the kilovoltage (kV) and milliamperage (mA) values do not lock immediately after the user selects the Lock-in command. These values can adjust if the collimator shutter position is changed directly after the command is issued.
The affected units were distributed nationwide. The source text does not specify the number of reported injuries, illnesses, or deaths associated with this defect. The issue is a functional software error that may impact the stability of exposure parameters during fluoroscopic procedures.
Healthcare facilities using these systems should contact Philips Home Healthcare Solutions for instructions on how to resolve the issue. Consumers and patients should consult their healthcare providers regarding any recent imaging performed on these devices.
The recalled product
- Product
- ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system
- Manufacturer
- PHILIPS HOME HEALTHCARE SOLUTION
- Affected units
- 91
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)
- Pending
Distribution
Distributed nationwide across the United States.
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