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Philips North America Llc

265 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Achieva 1.5T Initial System recall (Z-0391-2024)Philips North America Llc2023-11-21
Ingenia 1.5T CX recall (Z-0392-2024)Philips North America Llc2023-11-21
Intera 1.5T recall (Z-0393-2024)Philips North America Llc2023-11-21
Intera 1.5T Power/Pulsar recall (Z-0394-2024)Philips North America Llc2023-11-21
SmartPath to dStream for 1.5T recall (Z-0395-2024)Philips North America Llc2023-11-21
Big Bore RT with software version V4.8.0.10421- Model: 728242 CT scanner and simulator des recall (Z-0292-2024)Philips North America Llc2023-11-14
Brilliance CT Big Bore with software version V4.8.0.10421 Model:728244 CT scanner and simu recall (Z-0293-2024)Philips North America Llc2023-11-14
Brilliance CT Big Bore Oncology with software version V4.8.0.10421 Model:728243 CT scanner recall (Z-0294-2024)Philips North America Llc2023-11-14
CombiDiagnost R90, Radiography and Fluoroscopy (R/F) system recall (Z-0271-2024)Philips North America Llc2023-11-08
DigitalDiagnost 4 Chest/Emergency, used to acquire, process, store, display and export dig recall (Z-0272-2024)Philips North America Llc2023-11-08
DigitalDiagnost 4 Flex/Value, used to acquire, process, store, display and export digital recall (Z-0273-2024)Philips North America Llc2023-11-08
DigitalDiagnost 4 High Performance, used to acquire, process, store, display and export di recall (Z-0274-2024)Philips North America Llc2023-11-08
DigitalDiagnost C90 Flex/Value/Chest/ER, used to acquire, process, store, display and expo recall (Z-0275-2024)Philips North America Llc2023-11-08
DigitalDiagnost C90 High Performance, used to acquire, process, store, display and export recall (Z-0276-2024)Philips North America Llc2023-11-08
DigitalDiagnost C90 Release 3, used to acquire, process, store, display and export digital recall (Z-0277-2024)Philips North America Llc2023-11-08
DigitalDiagnost C90 Release 3.1, used to acquire, process, store, display and export digit recall (Z-0278-2024)Philips North America Llc2023-11-08
EasyDiagnost Eleva DRF, Release 5, used to acquire, process, store, display and export dig recall (Z-0279-2024)Philips North America Llc2023-11-08
ProxiDiagnost N90, Radiography and Fluoroscopy (R/F) system recall (Z-0280-2024)Philips North America Llc2023-11-08
EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 recall (Z-2654-2023)Philips North America Llc2023-09-29
EarlyVue VS30 Vital Signs Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) an recall (Z-2655-2023)Philips North America Llc2023-09-29
Patient Information Center iX with Software Version Number 4.x in the following: (1) Patie recall (Z-2608-2023)Philips North America Llc2023-09-19
DigitalDiagnost C90, Model No. 712034 and 712035 recall (Z-2042-2023)Philips North America Llc2023-06-30
EARLYVUE VS30 VITAL SIGNS MONITOR Software Version A.00.02 and A.00.01 Product Number: 863 recall (Z-1644-2023)Philips North America Llc2023-05-26
EarlyVue VS30 Vitals monitor with Software Versions A.00.02 and A.00.01 Product Number: 86 recall (Z-1645-2023)Philips North America Llc2023-05-26
Spectral CT 7500 Computed Tomography X-Ray System, Model Number 728333 recall (Z-1584-2023)Philips North America Llc2023-05-12
Philips ProxiDiagnost N90 1.0 (Model 706100) and ProxiDiagnost N90 1.1 (Model 706110)- A m recall (Z-1477-2023)Philips North America Llc2023-04-28
Philips DigitalDiagnost C50 -intended for use in generating radiographic images of human a recall (Z-1382-2023)Philips North America Llc2023-04-12
DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatom recall (Z-1383-2023)Philips North America Llc2023-04-12
CombiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 709030 an recall (Z-1355-2023)Philips North America Llc2023-04-10
ProxiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 706100 an recall (Z-1356-2023)Philips North America Llc2023-04-10
Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate monitoring recall (Z-0908-2023)Philips North America Llc2023-01-06
Philips Ingenia Elition S MR System, Model Numbers 781357, 782106, 782137 recall (Z-0459-2023)Philips North America Llc2022-12-08
Philips Ingenia Elition X MR System, Model Numbers 781358, 782107, 782119, 782136 recall (Z-0460-2023)Philips North America Llc2022-12-08
Philips SmartPath to Ingenia Elition X MR System, Model Numbers 782118, 782132, 782144 recall (Z-0461-2023)Philips North America Llc2022-12-08
Philips MR 7700 System, Model Number 782120 recall (Z-0462-2023)Philips North America Llc2022-12-08
Philips Upgrade to MR 7700 System, Model Number 782130 recall (Z-0463-2023)Philips North America Llc2022-12-08
MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a component recall (Z-0004-2023)Philips North America Llc2022-10-04
DigitalDiagnost C50 1.1 recall (Z-1563-2022)Philips North America Llc2022-09-01
Philips, REF M5071A, Adult. Smart PADS CARTRIDGE, 8+ years FOR USE WITH HEARSTART HS1 DEFI recall (Z-0881-2022)Philips North America LLC2022-04-06
Philips, REF M5072A, INFANT/CHILD - SMART PADS CARTRIDGE (0-8 YEARS). Smart PADS CARTRIDGE recall (Z-0882-2022)Philips North America LLC2022-04-06
Infant Heel Warmers w/strap, Reference # 989805603201 1223 recall (Z-0506-2022)Philips North America Llc2022-01-19
Heel Snuggler, Reference # 989805603411 99047 recall (Z-0507-2022)Philips North America Llc2022-01-19
Cardinal Infant Heel Warmer, Reference # 989805617251 11470-010T recall (Z-0508-2022)Philips North America Llc2022-01-19
Medichoice Infant Heel Warmer, Reference # 989805643721 1079906 recall (Z-0509-2022)Philips North America Llc2022-01-19
Infa-Therm Transport Mattress, Reference Number 989805616831 1015 recall (Z-0505-2022)Philips North America Llc2022-01-18
Wireless Footswtich used with the following Philips Allura Xper and Azurion Interventional recall (Z-0476-2022)Philips North America Llc2022-01-10
Philips, HeartStart FR2 + Defibrillator, Model # M3860A and M3861A recall (Z-0078-2022)Philips North America LLC2021-10-08
Philips, HeartStart FRx + Defibrillator, Model # Model #s: 861304 recall (Z-0079-2022)Philips North America LLC2021-10-08
Philips, HeartStart HS1 Home Defibrillator, Model # Model number: M5068A recall (Z-0080-2022)Philips North America LLC2021-10-08
Philips, HeartStart HS1 OnSite Defibrillator, Model #'s: M5066A and M5067A recall (Z-0081-2022)Philips North America LLC2021-10-08
Philips, HEARTSTART, INFANT/CHILD - SMART PADS CARTRIDGE, REF: M5072A, (0-8 YEARS)< 55 lbs recall (Z-2427-2021)Philips North America LLC2021-09-03
Ingenia Ambition X - Model Number: 781356, Diagnostic MR system. ***Updated November 2023* recall (Z-1795-2021)Philips North America Llc2021-06-04
Ingenia Ambition S - Model Number: 781359 Diagnostic MR system. recall (Z-1796-2021)Philips North America Llc2021-06-04
EasyDiagnost Eleva DRF, model no. 706050 - Product Usage: X-ray system, diagnostic, genera recall (Z-2523-2020)Philips North America, LLC2020-07-10
Philips Brilliance iCT Computed Tomography X-Ray System; Model # 728306; UDI #s (01)008848 recall (Z-1921-2020)Philips North America, LLC2020-05-06
Philips Brilliance iCT SP Computed Tomography X-Ray System; Model # 728311 recall (Z-1922-2020)Philips North America, LLC2020-05-06
Philips Brilliance IQon Spectral CT, Computed Tomography X-Ray System; Model # 728332; UDI recall (Z-1923-2020)Philips North America, LLC2020-05-06
Philips Azurion 7 M20 -XperGuide Software hosted in Interventional Workspot 1.5 when used recall (Z-1809-2020)Philips North America, LLC2020-04-29
TRx4851A 2.4 GHz IntelliVue Tele TRX, Model Number 862231; Includes Service Numbers 453564 recall (Z-1766-2020)Philips North America, LLC2020-04-23
TRx4841A 1.4 GHz IntelliVue Tele TRX, Model Number 862439; Includes System Codes 453564007 recall (Z-1767-2020)Philips North America, LLC2020-04-23
VesselNavigator application used with Philips Azurion (Azurion 7 Series) Software R1.2 and recall (Z-1145-2020)Philips North America, LLC2020-02-10
HeartStart XL+ Defibrillator/Monitor, Model 861290 recall (Z-0498-2020)Philips North America, LLC2019-11-19
Philips HeartStart MRx devices in use with the M3539A AC Power Module: M3535A, M3536A, M35 recall (Z-1923-2019)Philips North America, LLC2019-07-05
MRx Defibrillator Model # M3535A & M3536A, UDI 00884838000018(21)US00601969 Product Usage: recall (Z-0489-2018)Philips North America, LLC2018-02-08
HeartStart MRx Monitor/Defibrillator, Model numbers: M3535A (M3535ATZ) M3536A (M3536ATZ), recall (Z-1417-2017)Philips North America, LLC2017-03-24
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