Philips ProxiDiagnost N90 Recalled for Potential Transformer Overheating and Smoke
Philips is recalling 91 ProxiDiagnost N90 units because defective thermo switches may fail to power down the system, causing the transformer to overheat and generate smoke.
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 (potential smoke generation) where injury has not yet been reported, fitting the 'High' severity criteria for theoretical hazards without confirmed illness or injury.
Plain-English summary
Philips North America, LLC is recalling 91 units of the ProxiDiagnost N90 (UDI 706100) medical device. The recall is due to a defect in the thermo switches within the three-phase transformer. These switches are designed to aid in powering down the System Power Distribution Unit but may be incorrectly installed and non-functional.
If the transformer overheats due to a primary failure and the thermo switch does not activate, the device may begin to generate smoke. The affected units were distributed domestically nationwide and to Chile and Germany. Specific serial numbers for the 91 affected units are listed in the official recall documentation.
Healthcare facilities and users should stop using the affected ProxiDiagnost N90 units immediately. Users should contact Philips North America, LLC for instructions on how to return the device or receive a replacement, as per the recall instructions provided by the manufacturer.
The recalled product
- Product
- ProxiDiagnost N90, UDI 706100
- Manufacturer
- Philips North America, LLC
- Hazard
- Affected units
- 91
Distribution
Distributed nationwide across the United States.
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