Philips North America, LLC ProxiDiagnost N90 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ProxiDiagnost N90
Brand
Philips North America, LLC
Lot Codes / Batch Numbers
All ProxiDiagnost N90 systems are affected.
Products Sold
All ProxiDiagnost N90 systems are affected.
Philips North America, LLC is recalling ProxiDiagnost N90 due to Unexpected increase in peak tube potential (kV) will lead to an increased patient radiation dose.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Unexpected increase in peak tube potential (kV) will lead to an increased patient radiation dose.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026