Royal Philips

Warning LetterOpen

Roy Jakobs Chief Executive Officer Royal Philips Amstelplein 2 1096 BC Amsterdam Netherlands (b)(6)@philips.comFEI 3019216Issued Sep 9, 2025Center for Devices and Radiological Health

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3019216.

Letter Details

Firm: Royal Philips
Location: Roy Jakobs Chief Executive Officer Royal Philips Amstelplein 2 1096 BC Amsterdam Netherlands (b)(6)@philips.com
FEI Number: 3019216
Country: Netherlands
Issue Date: September 09, 2025
Issuing Office: Center for Devices and Radiological Health
Product Type: Medical Devices
Status: Open

Summary

Royal Philips received a warning letter for quality system regulation (QSR) violations across three ultrasound and medical device manufacturing facilities in Washington, Pennsylvania, and the Netherlands. FDA inspections conducted between January and March 2025 determined that devices including the EPIQ Elite Ultrasound system, ultrasound transducers, IntelliSpace Cardiovascular, and eCareManager were adulterated because manufacturing methods, facilities, and controls failed to comply with current good manufacturing practice (CGMP) requirements under 21 CFR Part 820. The violations were identified across Philips Ultrasound's Bothell and Reedsville facilities and Philips Medical Systems Nederland B.V., with the company providing multiple response submissions to FDA in February, March, and April 2025.