Philips North America ProxiDiagnost N90 R.1.0 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ProxiDiagnost N90 R.1.0
Brand
Philips North America
Lot Codes / Batch Numbers
REF number 706100 Serial number 10001015, 10001019, 10001020, 10001021, 10001022, 10001023, 10001026, 10001027, 10001028, 10001030, 10001033, 10001036, 10001037, 10001038, 10001039, 10001040, 10001042, 10001051, 20000067.
Products Sold
REF number 706100 Serial number 10001015, 10001019, 10001020, 10001021, 10001022, 10001023, 10001026, 10001027, 10001028, 10001030, 10001033, 10001036, 10001037, 10001038, 10001039, 10001040, 10001042, 10001051, 20000067.
Philips North America is recalling ProxiDiagnost N90 R.1.0 due to Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 and CombiDiagnost R90 R1.1 systems are missing a cert. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 and CombiDiagnost R90 R1.1 systems are missing a certification label required by the Food and Drug Administration (FDA).
Recommended Action
Per FDA guidance
Philips sent an Electronic Product Radiation Correction letter dated March 3, 2023, to affected customers. The letter stated a Philips representative will contact affected customers to schedule a time for a Field Service Engineer (FSE) to visit your site to inspect your system and apply the label if necessary. Philips will, without charge, remedy the defect or bring the product into compliance with each applicable Federal standard in accordance with a plan approved by the Secretary of Health and Human Services. Customers were asked to complete and return the attached acknowledgement form to Philips DXR promptly upon receipt and no later than 30 days from receipt via email to: PD.CNR@philips.com. If you need any further information or support concerning this issue, please contact your local Philips Customer Care Solutions center: 1-800-722-9377 (Reference FCO70600112 for ProxiDiagnost N90 R.1.0 and FCO70900060 for CombiDiagnost R90 R.1.0 and R1.1).
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