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Philips North America Llc

265 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Cardiac Workstation 5000. Product Number: 860439. recall (Z-2955-2026)Philips North America Llc2026-08-14
Cardiac Workstation 7000. Product Number: 860441. recall (Z-2956-2026)Philips North America Llc2026-08-14
Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following syste recall (Z-2579-2026)Philips North America Llc2026-06-24
Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A recall (Z-2522-2026)Philips North America Llc2026-06-22
Philips Avalon Fetal Monitor, FM 30 Part numberM2703A recall (Z-2523-2026)Philips North America Llc2026-06-22
DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035. recall (Z-2354-2026)Philips North America Llc2026-06-05
Brilliance iCT; Product Code (REF): 728306; recall (Z-1315-2026)Philips North America Llc2026-02-06
IQon Spectral CT; Product Code (REF): 728332; recall (Z-1316-2026)Philips North America Llc2026-02-06
Spectral CT; Product Code (REF): 728333; recall (Z-1317-2026)Philips North America Llc2026-02-06
Spectral CT 7500 on Rails; Product Code (REF): 728334; recall (Z-1318-2026)Philips North America Llc2026-02-06
Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor. recall (Z-1033-2026)Philips North America Llc2026-01-08
Incisive CT; Software Version Number: 4.5, 5.0, 5.1; recall (Z-0881-2026)Philips North America Llc2025-12-03
CT 5300; Software Version Number: 4.5, 5.0, 5.1; recall (Z-0882-2026)Philips North America Llc2025-12-03
IntelliVue MP2. Product Number: M8102A. recall (Z-0849-2026)Philips North America Llc2025-12-02
IntelliVue MP5. Product Number: M8105A. recall (Z-0850-2026)Philips North America Llc2025-12-02
IntelliVue MP20. Product Number: M8001A. recall (Z-0851-2026)Philips North America Llc2025-12-02
IntelliVue MP30. Product Number: M8002A. recall (Z-0852-2026)Philips North America Llc2025-12-02
IntelliVue MP40. Product Number: M8003A. recall (Z-0853-2026)Philips North America Llc2025-12-02
IntelliVue MP50. Product Number: M8004A. recall (Z-0854-2026)Philips North America Llc2025-12-02
IntelliVue MP60. Product Number: M8005A. recall (Z-0855-2026)Philips North America Llc2025-12-02
IntelliVue MP70. Product Number: M8007A. recall (Z-0856-2026)Philips North America Llc2025-12-02
IntelliVue MP80. Product Number: M8008A. recall (Z-0857-2026)Philips North America Llc2025-12-02
IntelliVue MP90. Product Number: M8010A. recall (Z-0858-2026)Philips North America Llc2025-12-02
IntelliVue Multi Measurement Server X2. Product Number: M3002A. recall (Z-0859-2026)Philips North America Llc2025-12-02
IntelliVue Multi-Measurement Module X3. Product Number: 867030. recall (Z-0860-2026)Philips North America Llc2025-12-02
IntelliVue Patient Monitor MX100. Product Number: 867033. recall (Z-0861-2026)Philips North America Llc2025-12-02
IntelliVue Patient Monitor MX400. Product Number: 866060. recall (Z-0862-2026)Philips North America Llc2025-12-02
IntelliVue Patient Monitor MX450. Product Number: 866062. recall (Z-0863-2026)Philips North America Llc2025-12-02
IntelliVue Patient Monitor MX500. Product Number: 866064. recall (Z-0864-2026)Philips North America Llc2025-12-02
IntelliVue Patient Monitor MX550. Product Number: 866066. recall (Z-0865-2026)Philips North America Llc2025-12-02
IntelliVue Patient Monitor MX600. Product Number: 865242. recall (Z-0866-2026)Philips North America Llc2025-12-02
IntelliVue Patient Monitor MX700. Product Number: 865241. recall (Z-0867-2026)Philips North America Llc2025-12-02
IntelliVue Patient Monitor MX750. Product Number: 866471. recall (Z-0868-2026)Philips North America Llc2025-12-02
IntelliVue Patient Monitor MX800. Product Number: 865240. recall (Z-0869-2026)Philips North America Llc2025-12-02
IntelliVue Patient Monitor MX850. Product Number: 866470. recall (Z-0870-2026)Philips North America Llc2025-12-02
Philips CT systems labeled as the following: 1. Brilliance CT 40 Channel, Model Number: 72 recall (Z-2595-2025)Philips North America Llc2025-09-19
Philips CT systems labeled as the following: 1. Brilliance 16 Power, Model Number: 728240. recall (Z-2596-2025)Philips North America Llc2025-09-19
Philips CT systems labeled as the following: 1. Big Bore RT, Model Number: 728242. 2. Bril recall (Z-2597-2025)Philips North America Llc2025-09-19
Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306. recall (Z-2598-2025)Philips North America Llc2025-09-19
Philips CT systems labeled as the following: 1. Brilliance iCT SP, Model Number: 728311. recall (Z-2599-2025)Philips North America Llc2025-09-19
Philips CT systems labeled as the following: 1. Ingenuity CT 728326, Model Number: 728321. recall (Z-2600-2025)Philips North America Llc2025-09-19
Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Number: 728332. recall (Z-2601-2025)Philips North America Llc2025-09-19
Philips CT systems labeled as the following: 1. Ingenuity Core128 / Elite China, Model Num recall (Z-2602-2025)Philips North America Llc2025-09-19
Philips CT systems labeled as the following: 1. Ingenuity CT Family Brazil, Model Number: recall (Z-2603-2025)Philips North America Llc2025-09-19
Philips CT systems labeled as the following: 1. CT 6000, Model Number: 728307. recall (Z-2604-2025)Philips North America Llc2025-09-19
Spectral CT. Computed tomography X-ray system. recall (Z-2034-2025)Philips North America Llc2025-06-26
Product Name: SmartPath to dStream for 1.5T; Model Numbers: (1) 781260, (2) 782112, (3) 78 recall (Z-1788-2025)Philips North America Llc2025-05-16
Product Name: SmartPath to dStream for 3.0T; Model Number: 782145 recall (Z-1789-2025)Philips North America Llc2025-05-16
Product Name: SmartPath to dStream for XR and 3.0T; Model Numbers: (1) 781270, (2) 782113; recall (Z-1790-2025)Philips North America Llc2025-05-16
Product Name: SmartPath to Ingenia Elition X; Model Numbers: (1) 782118, (2) 782144; recall (Z-1791-2025)Philips North America Llc2025-05-16
Product Name: Upgrade to MR 7700; Model Number: 782130; recall (Z-1792-2025)Philips North America Llc2025-05-16
Product Name: Evolution Upgrade 1.5T; Model Numbers: (1) 782116, (2) 782148; recall (Z-1793-2025)Philips North America Llc2025-05-16
Product Name: Evolution Upgrade 3.0T; Model Numbers: (1) 782117, (2) 782143; recall (Z-1794-2025)Philips North America Llc2025-05-16
Product Name: Ingenia 1.5T; Model Numbers: (1) 781315, (2) 781341, (3) 781396, (4) 782101, recall (Z-1795-2025)Philips North America Llc2025-05-16
Product Name: Ingenia 1.5T S; Model Number: 781347; recall (Z-1796-2025)Philips North America Llc2025-05-16
Product Name: Ingenia 3.0T; Model Numbers: (1) 781342, (2) 781377, (3) 782103; recall (Z-1797-2025)Philips North America Llc2025-05-16
Product Name: Ingenia Ambition S; Model Numbers: (1) 781359, (2) 782108, (3) 782139; recall (Z-1798-2025)Philips North America Llc2025-05-16
Product Name: Ingenia 1.5T CX; Model Number: 781262; recall (Z-1799-2025)Philips North America Llc2025-05-16
Product Name: Ingenia 3.0T CX; Model Number: 781271; recall (Z-1800-2025)Philips North America Llc2025-05-16
Product Name: Ingenia Ambition X; Model Numbers: (1) 781356, (2) 782109, (3) 782138; recall (Z-1801-2025)Philips North America Llc2025-05-16
Product Name: Ingenia Elition S; Model Numbers: (1) 781357, (2) 782106, (3) 782137; recall (Z-1802-2025)Philips North America Llc2025-05-16
Product Name: Ingenia Elition X; Model Numbers: (1) 781358, (2) 782107, (3) 782136; recall (Z-1803-2025)Philips North America Llc2025-05-16
Product Name: MR 5300; Model Numbers: (1) 782110, (2) 782152; recall (Z-1804-2025)Philips North America Llc2025-05-16
Product Name: MR 7700; Model Numbers: (1) 782120, (2) 782153; recall (Z-1805-2025)Philips North America Llc2025-05-16
Microstream Advance Neonatal-Infant Intubated CO2 Filter Line marketed as Adt/Pedi Intub C recall (Z-1722-2025)Philips North America Llc2025-05-05
Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray Sy recall (Z-1660-2025)Philips North America Llc2025-04-23
Zenition 50. Product Code 718096. The devices are used for radiological guidance and visua recall (Z-1580-2025)Philips North America Llc2025-04-21
Zenition 70. Product Code 718133. The devices are used for radiological guidance and visua recall (Z-1581-2025)Philips North America Llc2025-04-21
Veradius Unity. Product Code 718132. The devices are used for radiological guidance and vi recall (Z-1582-2025)Philips North America Llc2025-04-21
Philips DXR System, DuraDiagnost 4.1. Stationary X-Ray System. recall (Z-1553-2025)Philips North America Llc2025-04-11
Philips DXR System, DuraDiagnost Rel. 4. Stationary X-Ray System. recall (Z-1554-2025)Philips North America Llc2025-04-11
IntelliBridge EC10 Module. Model Number: 865115 recall (Z-1106-2025)Philips North America Llc2025-02-05
IntelliVue Patient Monitor MX400. Model Number: 866060 recall (Z-1107-2025)Philips North America Llc2025-02-05
IntelliVue Patient Monitor MX450. Model Number: 866062 recall (Z-1108-2025)Philips North America Llc2025-02-05
IntelliVue Patient Monitor MX500. Model Number: 866064 recall (Z-1109-2025)Philips North America Llc2025-02-05
IntelliVue Patient Monitor MX550. Model Number: 866066 recall (Z-1110-2025)Philips North America Llc2025-02-05
Philips Smart-Hopping 2.0 AP 1.4 GHz. Model Number: 867216 recall (Z-0686-2025)Philips North America Llc2024-12-17
Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344. recall (Z-0583-2025)Philips North America Llc2024-12-03
Achieva TX Interventional Coil 3.0T recall (Z-0536-2025)Philips North America Llc2024-11-25
dS Breast 16ch 1.5T recall (Z-0537-2025)Philips North America Llc2024-11-25
dS Breast 16ch 3.0T recall (Z-0538-2025)Philips North America Llc2024-11-25
dS Breast 7ch 1.5T recall (Z-0539-2025)Philips North America Llc2024-11-25
dS Breast 7ch 3.0T recall (Z-0540-2025)Philips North America Llc2024-11-25
Mammotrak Diagnostic Coil 1.5T recall (Z-0541-2025)Philips North America Llc2024-11-25
Mammotrak Interventional Coil 1.5T recall (Z-0542-2025)Philips North America Llc2024-11-25
Mammotrak Diagnostic Coil 3.0T recall (Z-0543-2025)Philips North America Llc2024-11-25
Mammotrak Interventional Coil 3.0T recall (Z-0544-2025)Philips North America Llc2024-11-25
SENSE Breast Coil recall (Z-0545-2025)Philips North America Llc2024-11-25
SENSE Breast Coil 3.0T 7ch recall (Z-0546-2025)Philips North America Llc2024-11-25
ST SENSE Breast Coil recall (Z-0547-2025)Philips North America Llc2024-11-25
ST SENSE Breast Dx Coil recall (Z-0548-2025)Philips North America Llc2024-11-25
IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and order recall (Z-0020-2025)Philips North America Llc2024-10-04
DIVA 24 Inch Widescreen LCD Touch Display - Used with the Philips PIC iX system central mo recall (Z-3312-2024)Philips North America Llc2024-09-30
Evolution Upgrade 3.0T - For use as a diagnostic device to obtain cross-sectional images, recall (Z-3193-2024)Philips North America Llc2024-09-20
Ingenia 1.5T -For use as a diagnostic device to obtain cross-sectional images, spectroscop recall (Z-3194-2024)Philips North America Llc2024-09-20
Ingenia 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectrosco recall (Z-3195-2024)Philips North America Llc2024-09-20
Ingenia 3.0T CX - For use as a diagnostic device to obtain cross-sectional images, spectro recall (Z-3196-2024)Philips North America Llc2024-09-20
Ingenia Ambition S - For use as a diagnostic device to obtain cross-sectional images, spec recall (Z-3197-2024)Philips North America Llc2024-09-20
Ingenia Ambition X - For use as a diagnostic device to obtain cross-sectional images, spec recall (Z-3198-2024)Philips North America Llc2024-09-20
Ingenia Elition S -For use as a diagnostic device to obtain cross-sectional images, spectr recall (Z-3199-2024)Philips North America Llc2024-09-20
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