Chrysalis Intelligence · Sponsors · Philips Medical Systems

Philips Medical Systems

Shanghai, CN · 5 510(k) clearances · 53 PMAs · 8 recalls

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Total clearances
5
2020-04-16 → 2021-09-24
Last 12 months
0
Product codes
3
Most recent
2021-09-24
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
IYN System, Imaging, Pulsed Doppler, Ultrasonic Class II Radiology 2 2021-09-24
DPS Electrocardiograph Class II Cardiovascular 2 2021-06-30
DRG — — — 1 2020-04-16
Class III

PMA approvals (53)

Total PMA records
53
Originals + supplements
Distinct product codes
2
First decision
2020-05-11
Most recent
2026-05-21
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-05-21 P180028-S019 HeartStart FRx Defibrillator (861304) Real-Time Process MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2026-05-21 P160028-S007 HeartStart FR3 Text (861388) Defibrillator; HeartStart FR3 ECG (861389) Defibrillator Real-Time Process MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2026-02-02 P180028-S018 HeartStart FRx Defibrillator 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2026-02-02 P160029-S029 HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A) 30-Day Notice NSA — —
2025-09-05 P180028-S017 HeartStart FRx Defibrillator and HeartStart SMART Pads II 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2025-06-20 P160029-S028 HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A) 30-Day Notice NSA — —
2025-06-09 P180028-S016 HeartStart FRx Defibrillator (861304) 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2025-06-09 P160029-S027 HeartStart Home Defibrillator (M5068A) and HeartStart Onsite Defibrillator (M5066A) 30-Day Notice NSA — —
2025-05-09 P180028-S015 HeartStart FRx Defibrillator Special (Immediate Track) MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2025-05-09 P160028-S006 HeartStart FR3 Defibrillator Special (Immediate Track) MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2024-12-12 P160029-S026 HeartStart Home Defibrillator, HeartStart OnSite Defibrillator, HeartStart HS1 SMART Pads, Adult (M5071A), HeartStart HS Real-Time Process NSA — —
2024-09-11 P160028-S005 HeartStart FR3 Primary Battery (989803150161) Normal 180 Day Track No User Fee MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2024-02-21 P180028-S014 HeartStart FRx Defibrillator (861304) Normal 180 Day Track No User Fee MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2024-02-21 P160029-S024 HeartStart HS1 Onsite Defibrillator (M5066A), HeartStart HS1 Home Defibrillator (M5068A) Normal 180 Day Track No User Fee NSA — —
2024-01-23 P160029-S022 HeartStart OnSite Defibrillator, HeartStart Home Defibrillator, HeartStart HS1 SMART Pads, Adult, HeartStart HS1 SMART P 30-Day Notice NSA — —
2024-01-05 P160029-S023 HeartStart OnSite Defibrillator and HeartStart Home Defibrillator Special (Immediate Track) NSA — —
2023-12-19 P160029-S020 HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A) Real-Time Process NSA — —
2023-11-15 P160029-S021 HeartStart Onsite Defibrillator (M5066A), HeartStart Home Defibrillator (M5068A),HeartStart HS1 SMART Pads, Adult (M5071 30-Day Notice NSA — —
2023-04-03 P180028-S013 HeartStart FRx Defibrillator Real-Time Process MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2023-04-03 P160029-S019 HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A) Real-Time Process NSA — —
2023-02-16 P160029-S018 M5071A HS1 Adult SMART Pads Cartridge, M5072A HS1 Infant/Child SMART Pads Cartridge Real-Time Process NSA — —
2022-07-27 P160029-S017 HeartStart Onsite Defibrillator (M5066A), HeartStart Home Defibrillator (M5068A), HeartStart HS1 SMART Pads, Adult (M507 30-Day Notice NSA — —
2022-06-08 P160029-S016 HeartStart OnSite Defibrillator, HeartStart Home Defibrillator and HeartStart FRx Defibrillator 30-Day Notice NSA — —
2022-05-09 P160029-S014 HeartStart Onsite Defibrillator, HeartStart Home Defibrillator, HeartStart HS1 SMART Pads, Adult, HeartStart HS1 SMART P Real-Time Process NSA — —
2022-03-20 P180028-S012 HeartStart FRx Defibrillator 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2022-03-20 P160029-S015 HeartStart OnSite Home Defibrillator 30-Day Notice NSA — —
2021-11-15 P180028-S011 HeartStart FRx Defibrillator (861304) 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2021-09-24 P180028-S010 HeartStart FRx Defibrillator (861304) 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2021-08-10 P160029-S013 HeartStart OnSite Defibrillator, HeartStart Home Defibrillator, HS1 SMART Pads, Adult, HS1 SMART Pads, Infant/Child 30-Day Notice NSA — —
2021-06-15 P180028-S009 HeartStart FRx Defibrillator 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2021-06-15 P180028-S008 HeartStart FRx Defibrillator Special (Immediate Track) MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2021-06-15 P160029-S012 HeartStart OnSite Defibrillator and HeartStart Home Defibrillator 30-Day Notice NSA — —
2021-06-15 P160028-S004 HeartStart FR3 Defibrillator Special (Immediate Track) MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2021-04-19 P160029-S011 HeartStart Home Defibrillator and HeartStart Onsite Defibrillator 30-Day Notice NSA — —
2021-04-06 P180028-S005 HeartStart FRx Defibrillator Real-Time Process MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2021-04-06 P160029-S008 HeartStart OnSite and Home Defibrillator Real-Time Process NSA — —
2021-03-10 P180028-S007 HeartStart FRx Defibrillator 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2021-03-10 P160029-S010 HeartStart OnSite Defibrillator and HeartStart Home Defibrillator 30-Day Notice NSA — —
2021-02-12 P180028-S006 HeartStart FRx Defibrillator 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2021-02-12 P160029-S009 HeartStart Home Defibrillator and HeartStart OnSite Defibrillator 30-Day Notice NSA — —
2021-01-11 P160028-S002 Philips HeartStart FR3 Defibrillator Real-Time Process MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2020-12-16 P180028-S004 HeartStart FRx Defibrillator 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2020-12-16 P160029-S007 HeartStart OnSite Defibrillator, and HeartStart Home Defibrillator 30-Day Notice NSA — —
2020-12-16 P160028-S003 HeartStart FR3 Defibrillator 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2020-08-22 P180028-S003 HeartStart FRx Defibrillator 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2020-08-22 P160029-S006 HeartStart OnSite Defibrillator and HeartStart Home Defibrillator 30-Day Notice NSA — —
2020-08-03 P180028-S002 HeartStart FRx Defibrillator 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2020-08-03 P160029-S005 HeartStart Home Defibrillator and HeartStart Onsite Defibrillator 30-Day Notice NSA — —
2020-08-03 P160028-S001 HeartStart FR3 Defibrillator 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2020-07-16 P180028-S001 HeartStart FRx Defibrillator (861304) 30-Day Notice MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2020-07-16 P160029-S004 HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A) 30-Day Notice NSA — —
2020-05-11 P180028 HeartStart FRx Defibrillator Original MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
2020-05-11 P160028 Philips HeartStart FR3 Defibrillator Original MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular
Safety

Recalls (8)

Class I (serious)
0
Risk of injury / death
Total recalls
8
Currently ongoing
8
Most recent
2026-03-07
DateSeverityStatusRecall # ProductCodeReason
2026-03-07 Class II Ongoing Z-1825-2026 Philips Spectral CT on Rails. Model Number: 728334. — Philips has identified three software issues: 1. During a continuous CT (CCT) scan, there is the potential that the Gantry could remain at the current scan pos…
2025-09-25 Class II Ongoing Z-0377-2026 Model: Incisive CT for Brazil SKD; Product Code (REF): 728146; Software Versions: 5.1.0.X & 5.1.1.X; — Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2. When perf…
2025-09-25 Class II Ongoing Z-0376-2026 Model: CT 5300; Product Code (REF): 728285; Software Versions: 5.1.0.X & 5.1.1.X; — Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2. When perf…
2025-09-25 Class II Ongoing Z-0375-2026 Model: Incisive CT; Product Code (REF): (1) 728143, (2) 728144; Software Versions: 5.1.0.X & 5.1.1.X; — Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2. When perf…
2023-12-13 Class II Ongoing Z-1055-2024 Spectral CT 7500: Software Version 5.0, Model 728333 and Spectral CT 7500 China: Software Version 5.0, Model 728340. — A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment.
2023-12-13 Class II Ongoing Z-1054-2024 Spectral CT on Rails: Software Version 5.1.0.X, model 728334. — A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment.
2022-02-11 Class II Ongoing Z-1088-2024 CombiDiagnost R90 1.1 (709031) — While performing a fluoroscopy examination, there is a potential that the Radio Fluoroscopy (RF) viewer will also display a previous patient's radiography image…
2022-02-11 Class II Ongoing Z-1087-2024 CombiDiagnost R90 1.0 (709030) — While performing a fluoroscopy examination, there is a potential that the Radio Fluoroscopy (RF) viewer will also display a previous patient's radiography image…
Filings

All 510(k) clearances (5)

Date K-number Device Code Class Specialty
2021-09-24 K212704 Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System IYN Class II Radiology
2021-09-08 K211597 EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System IYN Class II Radiology
2021-06-30 K210560 Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 Cardiograph DPS Class II Cardiovascular
2020-09-29 K191738 PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, PageWriter TC50 Cardiograph, PageWriter TC70 Cardiograph DPS Class II Cardiovascular
2020-04-16 K192875 Philips Biosensor BX100 DRG — —
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence