Philips North America, LLC
Philips North America, LLC holds FDA 510(k) medical device clearance, cleared in 2021, with 410 FDA device recalls on record.
Top product codes for Philips North America, LLC
FDA recalls by Philips North America, LLC
10 most recent of 410- Z-3043-2026 — Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Brilliance CT 64 Upgrades Product Code: 728232. Software 4.1.10.x
- Z-3042-2026 — Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuity CT China 728324, Ingenuity Core 128 Elite Brazil 728325. Software 4.4.10.x
- Z-3041-2026 — Philips IQon Spectral CT Product Codes: IQon Spectral CT 728332, IQon Spectral CT 728331 Software 4.7.7.x
- Z-3040-2026 — Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP. Software 4.1.10.x Product Codes: 728306, 728305, 728311.
- Z-2955-2026 — Cardiac Workstation 5000. Product Number: 860439.
- Z-2956-2026 — Cardiac Workstation 7000. Product Number: 860441.
- Z-2579-2026 — Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following system descriptions: TELE Monitor 5500, 1.4 Ghz, ECG only, ex; Telemetry Monitor 5500 1.4 GHz FAST EX.
- Z-2522-2026 — Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A
- Z-2523-2026 — Philips Avalon Fetal Monitor, FM 30 Part numberM2703A
- Z-2354-2026 — DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Philips North America, LLC
Data sourced from openFDA. This site is unofficial and independent of the FDA.