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PHILIPS MEDICAL SYSTEMS

109 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Channel CT6000 B recall (Z-2650-2026)PHILIPS MEDICAL SYSTEMS2026-07-27
IQon Spectral CT IQon Spectral CT Upgrades recall (Z-2651-2026)PHILIPS MEDICAL SYSTEMS2026-07-27
Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro CT5000 Ingenuity Premium Ingenuity recall (Z-2652-2026)PHILIPS MEDICAL SYSTEMS2026-07-27
Philips Spectral CT on Rails. Model Number: 728334. recall (Z-1825-2026)PHILIPS MEDICAL SYSTEMS2026-04-16
Model: Incisive CT; Product Code (REF): (1) 728143, (2) 728144; Software Versions: 5.1.0.X recall (Z-0375-2026)PHILIPS MEDICAL SYSTEMS2025-10-27
Model: CT 5300; Product Code (REF): 728285; Software Versions: 5.1.0.X & 5.1.1.X; recall (Z-0376-2026)PHILIPS MEDICAL SYSTEMS2025-10-27
Model: Incisive CT for Brazil SKD; Product Code (REF): 728146; Software Versions: 5.1.0.X recall (Z-0377-2026)PHILIPS MEDICAL SYSTEMS2025-10-27
CombiDiagnost R90 1.0 (709030) recall (Z-1087-2024)PHILIPS MEDICAL SYSTEMS2024-02-14
CombiDiagnost R90 1.1 (709031) recall (Z-1088-2024)PHILIPS MEDICAL SYSTEMS2024-02-14
Spectral CT on Rails: Software Version 5.1.0.X, model 728334. recall (Z-1054-2024)PHILIPS MEDICAL SYSTEMS2024-02-08
Spectral CT 7500: Software Version 5.0, Model 728333 and Spectral CT 7500 China: Software recall (Z-1055-2024)PHILIPS MEDICAL SYSTEMS2024-02-08
DS/US Proton Feature with Pinnacle3 Software Version 10.0.0 and 14.0.0 Radiation Therapy P recall (Z-0745-2016)Philips Medical Systems2016-02-02
SKYLight Imaging Systems, Model 882050; Intended to produce images depicting the anatomica recall (Z-0607-2012)Philips Medical Systems2012-01-11
SKYLight Gamma Camera System; SKYLIGHT 8FT, 3/8" SPECT Manufactured by Philips Medical Sys recall (Z-0247-2012)Philips Medical Systems2011-11-19
SKYLight Gamma Camera System; SKYLIGHT 8FT, 5/8" SPECT Manufactured by Philips Medical Sys recall (Z-0248-2012)Philips Medical Systems2011-11-19
SKYLight Gamma Camera System; SKYLIGHT, 3/8",SPECT; Manufactured by Philips Medical System recall (Z-0249-2012)Philips Medical Systems2011-11-19
SKYLight Gamma Camera System; SKYLIGHT, 5/8",SPECT; Manufactured by Philips Medical System recall (Z-0250-2012)Philips Medical Systems2011-11-19
SKYLight Gamma Camera System; SKYLIGHT,AZ,8FT,3/8 Manufactured by Philips Medical Systems recall (Z-0251-2012)Philips Medical Systems2011-11-19
SKYLight Gamma Camera System; SKYLIGHT,AZ,8FT,5/8 Manufactured by Philips Medical Systems recall (Z-0252-2012)Philips Medical Systems2011-11-19
SKYLight Gamma Camera System; SKYLIGHT,AZ,9FT,3/8 Manufactured by Philips Medical Systems recall (Z-0253-2012)Philips Medical Systems2011-11-19
SKYLight Gamma Camera System; SKYLIGHT,AZ,9FT,5/8 Manufactured by Philips Medical Systems recall (Z-0254-2012)Philips Medical Systems2011-11-19
Precedence System; SYST,PRECEDENCE, 16 SLICE 5/8 Manufactured by Philips Medical Systems ( recall (Z-0255-2012)Philips Medical Systems2011-11-19
Precedence System; SYST,PRECEDENCE, 16 SLICE 3/8 Manufactured by Philips Medical Systems ( recall (Z-0256-2012)Philips Medical Systems2011-11-19
Precedence System; SYST,PRECEDENCE, 6 SLICE 3/8 Manufactured by Philips Medical Systems (C recall (Z-0257-2012)Philips Medical Systems2011-11-19
Precedence System; SYST,PRECEDENCE, 6 SLICE 5/8 Manufactured by Philips Medical Systems (C recall (Z-0258-2012)Philips Medical Systems2011-11-19
Extended Brilliance Workstation-NM (EBW-NM) with software version 1.0P, 1.1.1A, 1.5H, 1.5. recall (Z-0182-2012)Philips Medical Systems2011-11-10
BrightView X Gamma Camera, 3/8". Philips Medical Systems, Inc. Intended to produce images recall (Z-2947-2011)Philips Medical Systems2011-08-04
BrightView XCT Gamma Camera, 3/8". Philips Medical Systems, Inc. Intended to produce image recall (Z-2948-2011)Philips Medical Systems2011-08-04
BrightView XCT Gamma Camera, 3/4". Philips Medical Systems, Inc. Intended to produce image recall (Z-2949-2011)Philips Medical Systems2011-08-04
Philips brand BrightView Gamma Camera System, SYST, BRIGHTVIEW-FIXED, 3/8", Model Number: recall (Z-2867-2011)Philips Medical Systems2011-07-22
Philips brand BrightView Gamma Camera System, SYST, BRIGHTVIEW-FIXED, 3/8", Model Number: recall (Z-2868-2011)Philips Medical Systems2011-07-22
Philips brand BrightView Gamma Camera System, SYST, BRIGHTVIEW-TILT, 3/4", Model Number: 2 recall (Z-2869-2011)Philips Medical Systems2011-07-22
Philips brand BrightView Gamma Camera System, SYST, BRIGHTVIEW-TILT, 3/4", Model Number; 4 recall (Z-2870-2011)Philips Medical Systems2011-07-22
Philips brand BrightView Gamma Camera System, SYST, BRIGHTVIEW-TILT, 3/8", Model Number: 2 recall (Z-2871-2011)Philips Medical Systems2011-07-22
Philips brand BrightView Gamma Camera System, SYST, BRIGHTVIEW-TILT, 3/8", Model Number: 4 recall (Z-2872-2011)Philips Medical Systems2011-07-22
Brightview XCT, 3/8" Philips Medical Systems Brightview XCT is a gamma camera for Single P recall (Z-2155-2011)Philips Medical Systems2011-05-09
Brightview XCT, 3/4" Philips Medical Systems Brightview XCT is a gamma camera for Single P recall (Z-2156-2011)Philips Medical Systems2011-05-09
iSite PACS with Advanced Visualization Tools (AVT) R7.4V6L1, Versions: 3.6.87, 3.6.92, 4.1 recall (Z-1881-2011)Philips Medical Systems2011-04-04
iSite PACS with iSite ViewForum Applications, R7.4V6 L1 L2, L3, Versions: 3.6.96, 3.6.101, recall (Z-1882-2011)Philips Medical Systems2011-04-04
Precedence Imaging System; 16 Slice 5/8, 16 slice 3/8; Philips Medical Systems An imaging recall (Z-1549-2011)Philips Medical Systems2011-03-04
Precedence Imaging System; 6 Slice 3/8; 6 slice 5/8 Philips Medical Systems An imaging sys recall (Z-1550-2011)Philips Medical Systems2011-03-04
SKYLight 8 FT 3/8" SPECT; 9 FT 3/8", SPECT; 8 FT, 5/8" SPECT; and 9 FT 5/8" SPECT. Philips recall (Z-1551-2011)Philips Medical Systems2011-03-04
SKYLight, AZ 8 FT 3/8"; 8 FT, 5/8"; 9 FT 3/8"; and 9 FT 5/8". Philips Medical Systems Inte recall (Z-1552-2011)Philips Medical Systems2011-03-04
HeartStart FR2+ AED with ECG Display, Model M3860, Philips brand, configurable manual char recall (Z-0483-2011)Philips Medical Systems2010-11-29
HeartStart FR2+ AED with Text Display (No ECG), Model M3861, Philips brand, no configurabl recall (Z-0484-2011)Philips Medical Systems2010-11-29
HeartStart FR2+ AED with ECG Display, Model 3840, Laerdal brand, configurable manual charg recall (Z-0485-2011)Philips Medical Systems2010-11-29
HeartStart FR2+ AED with Text Display (No ECG), Model 3841, Laerdal brand, no configurable recall (Z-0486-2011)Philips Medical Systems2010-11-29
HeartStart FR2+ AED with ECG Display, Model 989803148601. This product is G2005 Update acc recall (Z-0487-2011)Philips Medical Systems2010-11-29
HeartStart FR2+ AED with Text Display, Model 989803148611. This product is G2005 Update in recall (Z-0488-2011)Philips Medical Systems2010-11-29
HeartStart FR2+ automated external defibrillator (AED) Model M3860: Philips brand; configu recall (Z-0470-2011)Philips Medical Systems2010-11-26
HeartStart FR2+ automated external defibrillator (AED) model: M3840: LAERDAL brand; config recall (Z-0471-2011)Philips Medical Systems2010-11-26
HeartStart FR2+ automated external defibrillator (AED) model: M3861: PHILIPS brand; text p recall (Z-0472-2011)Philips Medical Systems2010-11-26
HeartStart FR2+ automated external defibrillator (AED) model: M3841: LAERDAL brand; text p recall (Z-0473-2011)Philips Medical Systems2010-11-26
Philips HeartStart FRx Defibrillator, Automated External Defibrillator (AED), catalog numb recall (Z-0432-2011)Philips Medical Systems2010-11-22
SKYLight Gamma Camera Gearbox brake, a component of the SKYLight Gamma Cameras 3/8" SPECT, recall (Z-0398-2011)Philips Medical Systems2010-11-17
Automated External Defibrillator (AED) of brand name "Philips HeartStart FRx" (Model numbe recall (Z-1915-2010)Philips Medical Systems2010-06-28
Automated External Defibrillator(AED) of brand name "Philips HeartStart HS1 OnSite" (Model recall (Z-1916-2010)Philips Medical Systems2010-06-28
Automated External Defibrillator (AED) of brand name "Philips HeartStart HS1 Home" (Model recall (Z-1917-2010)Philips Medical Systems2010-06-28
Philips Heartstart FRx automated external defibrillator (AED), Model 861304 recall (Z-1193-2010)Philips Medical Systems2010-03-23
Philips Heartstart (HS1) Onsite Automated External Defibrillator (AED) Catalog number M506 recall (Z-1194-2010)Philips Medical Systems2010-03-23
Heartstart (HS1) Laerdal brand onsite Automated External Defibrillator, Model M5067A recall (Z-1195-2010)Philips Medical Systems2010-03-23
Heartstart HS1 Defibrillator Model M5068A recall (Z-1196-2010)Philips Medical Systems2010-03-23
Heartstart FR2+ automated external defibrillator models M3861A and M3841A are NOT equipped recall (Z-0062-2010)Philips Medical Systems2009-12-08
Heartstart FR2+ automated external defibrillator Models M3860A and M3840A are equipped wit recall (Z-0063-2010)Philips Medical Systems2009-12-08
Philips M8000-64100 Table Mount Shipped standard with all IntelliVue Patient Monitors MP40 recall (Z-0817-2009)Philips Medical Systems2009-01-13
Philips Diagnostic Ultrasound System, Model HD3. Product labeled HD3 Ultrasound System, Di recall (Z-0522-2009)Philips Medical Systems2008-12-31
Philips Diagnostic Ultrasound System, Model HDI4000. Product labeled HDI4000 Ultrasound Sy recall (Z-0523-2009)Philips Medical Systems2008-12-31
M3811B Philips Telemonitoring Clinical Review Software part of Philips Telemonitoring Syst recall (Z-0100-2009)Philips Medical Systems2008-10-10
HeartStarMRtX Defibrillator/Monitor Models: M3535A/M3536A HeartStart MRx with a native 256 recall (Z-2337-2008)Philips Medical Systems2008-09-25
Philips Telemonitoring System Software (M3811B) used with Philips Telemonitoring System (M recall (Z-2369-2008)Philips Medical Systems2008-09-18
Phillips Medical Systems, SureSigns VS3 Vital Signs Monitor model numbers 863071, 863072, recall (Z-1911-2008)Philips Medical Systems2008-09-16
Biopsy Guide Starter Kits C5-2 used with the Philips HD3 Ultrasound System intended for di recall (Z-2013-2008)Philips Medical Systems2008-09-16
Biopsy Guide Starter Kits C7-3 used with the Philips HD3 Ultrasound System intended for di recall (Z-2014-2008)Philips Medical Systems2008-09-16
Biopsy Guide Starter Kits L9-5 used with the Philips HD3 Ultrasound System intended for di recall (Z-2015-2008)Philips Medical Systems2008-09-16
CareVue Chart Release C ,Versions C.00.00 through C.00.06 Product No. 862246. This device recall (Z-1540-2008)Philips Medical Systems2008-08-23
IntelliVue Clinical Information Portfolio Critical Care Release D, Version D.00.00 Product recall (Z-1541-2008)Philips Medical Systems2008-08-23
Philips defibrillator, model M5066A. Sold in the US by Philips as an OTC under the brand n recall (Z-1779-2008)Philips Medical Systems2008-07-09
Laerdal "HeartStart Defibrillator", model M5067A, under Laerdal brand for Laerdal Medical recall (Z-1780-2008)Philips Medical Systems2008-07-09
Philips "HeartStart Home" defibrillator, model M5068A and is sold in the US over the count recall (Z-1781-2008)Philips Medical Systems2008-07-09
Philips PageWriter Touch Cardiograph, Model: 860284, Philips Medical Systems, Andover, MA, recall (Z-0124-2008)Philips Medical Systems2008-01-30
Philips Medical Systems, M3290A IntelliVue Information Center Software for M3170 Intellivu recall (Z-0451-2008)Philips Medical Systems2007-12-11
HeartStart XL Defibrillator/Monitor, Model: M4735A recall (Z-0062-2008)Philips Medical Systems2007-10-25
Intellivue Central Station Software for the: Intellivue Information Center; Philips Inform recall (Z-1182-2007)Philips Medical Systems2007-09-05
Philips Medical HeartStartXL Defibrillator/Monitor Model : M4735A recall (Z-1128-2007)Philips Medical Systems2007-08-07
HD11XE Diagnostic Ultrasound System recall (Z-0987-2007)Philips Medical Systems2007-07-03
Philips HeartStart FR2+ Defibrillator Automated External Defibrillator (AED) Catalog Numbe recall (Z-0641-2007)Philips Medical Systems2007-03-22
HeartStart FR2+ Defibrillator recall (Z-0308-2007)Philips Medical Systems2006-12-27
M3001A Philips Multi Measurement Server (MMS) recall (Z-0183-2007)Philips Medical Systems2006-11-16
M1020B PulseOximetry Module Philips FAST Sp02 and Pulse Oximetry Nellcor OxiMax Compatible recall (Z-0184-2007)Philips Medical Systems2006-11-16
IntelliVue MultiMeasurement Server (MMS)/Multimeasurement Server, physiological patient mo recall (Z-1487-06)Philips Medical Systems2006-09-12
HeartStart Pads Pediatric Plus, Pediatric Plus Multifunction Defibrillation Electrode Pads recall (Z-0321-06)Philips Medical Systems2005-12-23
Philips Medical HeartStart MRx Monitor/Defibrillator Model: M3535A, M3536A recall (Z-0848-05)Philips Medical Systems2005-05-17
Philips Heartstart MRx Monitor/Defibrillator Models: M3535A (Hospital Use) , M3536A (EMS U recall (Z-0341-05)Philips Medical Systems2004-12-21
Pagewriter Touch Cardiograph Software Versions A.01.01 or A.01.02 recall (Z-0063-05)Philips Medical Systems2004-11-02
Gyroscan ACS-NT system recall (Z-1199-03)Philips Medical Systems2003-09-12
Gyroscan NT-Intera 1.5T recall (Z-1200-03)Philips Medical Systems2003-09-12
Gyroscan 1.5T Intera recall (Z-1201-03)Philips Medical Systems2003-09-12
Diagnost 94 recall (Z-1203-03)Philips Medical Systems2003-09-12
Multidiagnost 96 recall (Z-1204-03)Philips Medical Systems2003-09-12
Multidiagnost 97 recall (Z-1205-03)Philips Medical Systems2003-09-12
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