CombiDiagnost R90 R.1.0
- Company
- Philips North America
- Recall Initiated
- March 3, 2023
- Posted
- May 15, 2023
- Recall Number
- Z-1588-2023
- Quantity
- 25 systems in total
- Firm Location
- Cambridge, MA
Reason for Recall
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).
Distribution
US Nationwide
Lot / Code Info
REF number 709030 Serial number 10001076
Root Cause
Radiation Control for Health and Safety Act
Action Taken
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).