FDA Device Recalls

Recalls / Firms / PHILIPS MEDICAL SYSTEMS

PHILIPS MEDICAL SYSTEMS

109 FDA device recalls on record.

DateClassProductReason
2025-09-25Model: Incisive CT; Product Code (REF): (1) 728143, (2) 728144; Software Versions: 5.1.0.X & 5.1.1.X
2025-09-25Model: Incisive CT for Brazil SKD; Product Code (REF): 728146; Software Versions: 5.1.0.X & 5.1.1.X;
2025-09-25Model: CT 5300; Product Code (REF): 728285; Software Versions: 5.1.0.X & 5.1.1.X;
2023-12-13Spectral CT 7500: Software Version 5.0, Model 728333 and Spectral CT 7500 China: Software Version 5.
2023-12-13Spectral CT on Rails: Software Version 5.1.0.X, model 728334.
2022-02-11CombiDiagnost R90 1.1 (709031)
2022-02-11CombiDiagnost R90 1.0 (709030)
2016-08-24Ingenuity Core Model Number 728321 Product Usage: Computed Tomography X-ray systems intended to prod
2016-08-24Ingenuity Core 128 Model Number 728323 Product Usage: Computed Tomography X-ray systems intended to
2016-08-24Ingenuity CT Model Number 728326 Product Usage: Computed Tomography X-ray systems intended to produ
2016-08-24Brilliance 64 CT Model Number 728231 Product Usage: Computed Tomography X-ray systems intended to p
2016-01-08DS/US Proton Feature with Pinnacle3 Software Version 10.0.0 and 14.0.0 Radiation Therapy Planning S
2011-12-08SKYLight Imaging Systems, Model 882050; Intended to produce images depicting the anatomical distrib
2011-09-27SKYLight Gamma Camera System; SKYLIGHT,AZ,9FT,3/8 Manufactured by Philips Medical Systems (Clevelan
2011-09-27Precedence System; SYST,PRECEDENCE, 16 SLICE 3/8 Manufactured by Philips Medical Systems (Cleveland
2011-09-27SKYLight Gamma Camera System; SKYLIGHT,AZ,8FT,5/8 Manufactured by Philips Medical Systems (Clevelan
2011-09-27SKYLight Gamma Camera System; SKYLIGHT, 5/8",SPECT; Manufactured by Philips Medical Systems (Clevela
2011-09-27SKYLight Gamma Camera System; SKYLIGHT,AZ,8FT,3/8 Manufactured by Philips Medical Systems (Clevelan
2011-09-27SKYLight Gamma Camera System; SKYLIGHT, 3/8",SPECT; Manufactured by Philips Medical Systems (Clevela
2011-09-27Precedence System; SYST,PRECEDENCE, 16 SLICE 5/8 Manufactured by Philips Medical Systems (Cleveland
2011-09-27Precedence System; SYST,PRECEDENCE, 6 SLICE 5/8 Manufactured by Philips Medical Systems (Cleveland),
2011-09-27Precedence System; SYST,PRECEDENCE, 6 SLICE 3/8 Manufactured by Philips Medical Systems (Cleveland),
2011-09-27SKYLight Gamma Camera System; SKYLIGHT 8FT, 5/8" SPECT Manufactured by Philips Medical Systems (Cle
2011-09-27SKYLight Gamma Camera System; SKYLIGHT,AZ,9FT,5/8 Manufactured by Philips Medical Systems (Clevelan
2011-09-27SKYLight Gamma Camera System; SKYLIGHT 8FT, 3/8" SPECT Manufactured by Philips Medical Systems (Cle
2011-09-15Extended Brilliance Workstation-NM (EBW-NM) with software version 1.0P, 1.1.1A, 1.5H, 1.5.1A and 2
2011-06-15BrightView XCT Gamma Camera, 3/8". Philips Medical Systems, Inc. Intended to produce images depicti
2011-06-15BrightView XCT Gamma Camera, 3/4". Philips Medical Systems, Inc. Intended to produce images depicti
2011-06-15BrightView X Gamma Camera, 3/8". Philips Medical Systems, Inc. Intended to produce images depicting
2011-06-03Philips brand BrightView Gamma Camera System, SYST, BRIGHTVIEW-TILT, 3/8", Model Number: 4535-602-79
2011-06-03Philips brand BrightView Gamma Camera System, SYST, BRIGHTVIEW-FIXED, 3/8", Model Number: 2170-3000A
2011-06-03Philips brand BrightView Gamma Camera System, SYST, BRIGHTVIEW-FIXED, 3/8", Model Number: 4535-602-7
2011-06-03Philips brand BrightView Gamma Camera System, SYST, BRIGHTVIEW-TILT, 3/4", Model Number; 4535-602-79
2011-06-03Philips brand BrightView Gamma Camera System, SYST, BRIGHTVIEW-TILT, 3/8", Model Number: 2170-3002A;
2011-06-03Philips brand BrightView Gamma Camera System, SYST, BRIGHTVIEW-TILT, 3/4", Model Number: 2170-3003A;
2011-03-28Brightview XCT, 3/8" Philips Medical Systems Brightview XCT is a gamma camera for Single Photon Em
2011-03-28Brightview XCT, 3/4" Philips Medical Systems Brightview XCT is a gamma camera for Single Photon Em
2011-02-23iSite PACS with Advanced Visualization Tools (AVT) R7.4V6L1, Versions: 3.6.87, 3.6.92, 4.1.87, and 4
2011-02-23iSite PACS with iSite ViewForum Applications, R7.4V6 L1 L2, L3, Versions: 3.6.96, 3.6.101, 3.6.110,
2010-12-28SKYLight 8 FT 3/8" SPECT; 9 FT 3/8", SPECT; 8 FT, 5/8" SPECT; and 9 FT 5/8" SPECT. Philips Medical S
2010-12-28Precedence Imaging System; 16 Slice 5/8, 16 slice 3/8; Philips Medical Systems An imaging system co
2010-12-28Precedence Imaging System; 6 Slice 3/8; 6 slice 5/8 Philips Medical Systems An imaging system combi
2010-12-28SKYLight, AZ 8 FT 3/8"; 8 FT, 5/8"; 9 FT 3/8"; and 9 FT 5/8". Philips Medical Systems Intended to p
2010-10-15SKYLight Gamma Camera Gearbox brake, a component of the SKYLight Gamma Cameras 3/8" SPECT, Model num
2010-09-22HeartStart FR2+ AED with Text Display, Model 989803148611. This product is G2005 Update in accorda
2010-09-22HeartStart FR2+ AED with ECG Display, Model M3860, Philips brand, configurable manual charge in adva
2010-09-22HeartStart FR2+ AED with Text Display (No ECG), Model 3841, Laerdal brand, no configurable manual ch
2010-09-22HeartStart FR2+ AED with Text Display (No ECG), Model M3861, Philips brand, no configurable manual c
2010-09-22HeartStart FR2+ AED with ECG Display, Model 989803148601. This product is G2005 Update according t
2010-09-22HeartStart FR2+ AED with ECG Display, Model 3840, Laerdal brand, configurable manual charge in advan
2010-05-28HeartStart FR2+ automated external defibrillator (AED) model: M3841: LAERDAL brand; text prompts onl
2010-05-28HeartStart FR2+ automated external defibrillator (AED) Model M3860: Philips brand; configurable ECG
2010-05-28HeartStart FR2+ automated external defibrillator (AED) model: M3840: LAERDAL brand; configurable E
2010-05-28HeartStart FR2+ automated external defibrillator (AED) model: M3861: PHILIPS brand; text prompts on
2010-04-30Automated External Defibrillator (AED) of brand name "Philips HeartStart HS1 Home" (Model Number M5
2010-04-30Automated External Defibrillator (AED) of brand name "Philips HeartStart FRx" (Model number 861304).
2010-04-30Automated External Defibrillator(AED) of brand name "Philips HeartStart HS1 OnSite" (Model number M5
2009-11-02Heartstart (HS1) Laerdal brand onsite Automated External Defibrillator, Model M5067A
2009-11-02Philips Heartstart (HS1) Onsite Automated External Defibrillator (AED) Catalog number M5066A
2009-11-02Heartstart HS1 Defibrillator Model M5068A
2009-11-02Philips Heartstart FRx automated external defibrillator (AED), Model 861304
2009-10-01Heartstart FR2+ automated external defibrillator models M3861A and M3841A are NOT equipped with the
2009-10-01Heartstart FR2+ automated external defibrillator Models M3860A and M3840A are equipped with an ECG M
2008-10-22Philips M8000-64100 Table Mount Shipped standard with all IntelliVue Patient Monitors MP40-70, Gas
2008-09-11M3811B Philips Telemonitoring Clinical Review Software part of Philips Telemonitoring System, M3810A
2008-08-12Philips Diagnostic Ultrasound System, Model HD3. Product labeled HD3 Ultrasound System, Distributed
2008-08-12Philips Diagnostic Ultrasound System, Model HDI4000. Product labeled HDI4000 Ultrasound System, Dis
2008-08-07Philips HeartStart FRx Defibrillator, Automated External Defibrillator (AED), catalog number 861304.
2008-07-22Philips Telemonitoring System Software (M3811B) used with Philips Telemonitoring System (M3810B) Re
2008-07-14HeartStarMRtX Defibrillator/Monitor Models: M3535A/M3536A HeartStart MRx with a native 256Mbyte int
2008-05-29Biopsy Guide Starter Kits C7-3 used with the Philips HD3 Ultrasound System intended for diagnostic u
2008-05-29Biopsy Guide Starter Kits C5-2 used with the Philips HD3 Ultrasound System intended for diagnostic u
2008-05-29Biopsy Guide Starter Kits L9-5 used with the Philips HD3 Ultrasound System intended for diagnostic u
2008-04-30Philips "HeartStart Home" defibrillator, model M5068A and is sold in the US over the counter. The
2008-04-30Laerdal "HeartStart Defibrillator", model M5067A, under Laerdal brand for Laerdal Medical Corp, Wapp
2008-04-30Philips defibrillator, model M5066A. Sold in the US by Philips as an OTC under the brand name Phili
2008-04-30Phillips Medical Systems, SureSigns VS3 Vital Signs Monitor model numbers 863071, 863072, 863073, 86
2008-03-04IntelliVue Clinical Information Portfolio Critical Care Release D, Version D.00.00 Product Number: 8
2008-03-04CareVue Chart Release C ,Versions C.00.00 through C.00.06 Product No. 862246. This device is a clin
2007-11-13Philips Medical Systems, M3290A IntelliVue Information Center Software for M3170 Intellivue Patient
2007-09-12Philips PageWriter Touch Cardiograph, Model: 860284, Philips Medical Systems, Andover, MA, 01810
2007-09-04HeartStart XL Defibrillator/Monitor, Model: M4735A
2007-07-16Intellivue Central Station Software for the: Intellivue Information Center; Philips Information Cent
2007-06-11Philips Medical HeartStartXL Defibrillator/Monitor Model : M4735A
2007-04-25HD11XE Diagnostic Ultrasound System
2007-02-28Philips HeartStart FR2+ Defibrillator Automated External Defibrillator (AED) Catalog Numbers: M3860
2006-12-19HeartStart FR2+ Defibrillator
2006-09-21M3001A Philips Multi Measurement Server (MMS)
2006-09-21M1020B PulseOximetry Module Philips FAST Sp02 and Pulse Oximetry Nellcor OxiMax Compatible used with
2006-07-24IntelliVue MultiMeasurement Server (MMS)/Multimeasurement Server, physiological patient monitoring s
2005-11-18HeartStart Pads Pediatric Plus, Pediatric Plus Multifunction Defibrillation Electrode Pads Model M
2005-04-29Philips Medical HeartStart MRx Monitor/Defibrillator Model: M3535A, M3536A
2004-12-15Philips Heartstart MRx Monitor/Defibrillator Models: M3535A (Hospital Use) , M3536A (EMS Use)
2004-10-13Pagewriter Touch Cardiograph Software Versions A.01.01 or A.01.02
2003-09-02Model M4735A HeartStart XL Defibrillator//Monitor
2003-06-27Easy Access Software releases 1.1, 5.2, 6.2 & 7.2
2003-01-10MultiDiagnost 4 - x-ray system, multi functional/universal system for general use.
2002-11-21Gyroscan NT-Intera
2002-11-21Gyroscan Intera 1.0T & 1.5T
2002-11-21Gyroscan ACS-NT with software versions R6x, R7x, R8x
2002-09-27Philips BV300 Mobile X-Ray System
2002-05-02Gyroscan ACS-NT system
2002-05-02Gyroscan NT-Intera 1.5T
2002-05-02Gyroscan 1.5T Intera
2002-02-20Diagnost 94
2002-02-20Multidiagnost 96
2002-02-20Multidiagnost 97
2002-02-13Easy Access PACS System with software Release 5, 6.2, or 7.2
2002-02-13EasyWeb