—#200328

Product

CombiDiagnost R90 R1.1

FDA product code: JAA — System, X-Ray, Fluoroscopic, Image-Intensified
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K203087
Affected lot / code info: REF number: 709031 Serial Number: 10001071, 10001072, 10001086, 10001087, 10001114

Why it was recalled

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).

Root cause (FDA determination)

Radiation Control for Health and Safety Act

Action the firm took

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).

Recalling firm

Firm: Philips North America
Address: 222 Jacobs St, Cambridge, Massachusetts 02141-2296

Distribution

Distribution pattern: US Nationwide

Timeline

Recall initiated: 2023-03-03
Posted by FDA: 2023-05-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #200328. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.