Recalls / —
—#183663
Product
ProxiDiagnost N90
- FDA product code
- OWB — Interventional Fluoroscopic X-Ray System
- Device class
- Class 2
- Medical specialty
- Radiology
- 510(k) numbers
- K173433
- Affected lot / code info
- All ProxiDiagnost N90 systems are affected.
Why it was recalled
Unexpected increase in peak tube potential (kV) will lead to an increased patient radiation dose.
Root cause (FDA determination)
Radiation Control for Health and Safety Act
Action the firm took
Philips sent an Urgent Field Safety Notice dated August 5, 2020 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were informed that Philips plans to correct the defect at no cost to customers by implementing a field correction involving the installation of a software update. A Philips Field Service Engineers will schedule an appointment with customers to install the software update.
Recalling firm
- Firm
- Philips North America, LLC
- Address
- 3000 Minuteman Rd, Andover, Massachusetts 01810-1032
Distribution
- Distribution pattern
- United States
Timeline
- Recall initiated
- 2019-11-20
- Terminated
- 2024-04-04
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #183663. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.