ProxiDiagnost N90
This recall has been terminated (originally issued November 20, 2019).
- Company
- Philips North America, Llc
- Recall Initiated
- November 20, 2019
- Terminated
- April 4, 2024
- Recall Number
- Z-3023-2020
- Quantity
- 71
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Unexpected increase in peak tube potential (kV) will lead to an increased patient radiation dose.
Distribution
United States
Lot / Code Info
All ProxiDiagnost N90 systems are affected.
Root Cause
Radiation Control for Health and Safety Act
Action Taken
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.
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