Recall Z-3023-2020 ยท OWB Interventional Fluoroscopic X-Ray System
Philips North America, LLC
ProxiDiagnost N90
| Date | Nov 20, 2019 |
| Status | Terminated |
| Reason | Unexpected increase in peak tube potential (kV) will lead to an increased patient radiation dose. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | 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. |
| Quantity | 71 |
| Distribution | United States |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173433 | ProxiDiagnost N90 Philips Medical Systems Dmc GmbH, Feb 5, 2018 |