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Philips North America

126 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Philips Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781196. 2. Model N recall (Z-1951-2026)Philips North America2026-04-27
Philips Achieva 1.5T Initial system with MR Elastography (MRE). 1. Model Number (REF): 781 recall (Z-1952-2026)Philips North America2026-04-27
Philips Achieva 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781278. recall (Z-1953-2026)Philips North America2026-04-27
Philips Evolution Upgrade 1.5T with MR Elastography (MRE). 1. Model Number (REF): 782116 2 recall (Z-1954-2026)Philips North America2026-04-27
Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782143. recall (Z-1955-2026)Philips North America2026-04-27
Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model N recall (Z-1956-2026)Philips North America2026-04-27
Philips Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF): 781262. recall (Z-1957-2026)Philips North America2026-04-27
Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model N recall (Z-1958-2026)Philips North America2026-04-27
Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Mode recall (Z-1959-2026)Philips North America2026-04-27
Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (REF): 781359. 2. M recall (Z-1960-2026)Philips North America2026-04-27
Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (REF): 781356. 2. M recall (Z-1961-2026)Philips North America2026-04-27
Philips Ingenia Elition S with MR Elastography (MRE). 1. Model Number (REF): 781357. 2. Mo recall (Z-1962-2026)Philips North America2026-04-27
Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Mo recall (Z-1963-2026)Philips North America2026-04-27
Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120. 2. Model Number recall (Z-1964-2026)Philips North America2026-04-27
Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Model Number (REF): 7 recall (Z-1965-2026)Philips North America2026-04-27
Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 7 recall (Z-1966-2026)Philips North America2026-04-27
Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). 1. Model Number ( recall (Z-1967-2026)Philips North America2026-04-27
Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): recall (Z-1968-2026)Philips North America2026-04-27
Philips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782130. recall (Z-1969-2026)Philips North America2026-04-27
Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR systems with SW ve recall (Z-1204-2026)Philips North America2026-01-29
Evolution Upgrade 3.0T. Product Code (REF): 782143. MR systems with SW version R11.1 and R recall (Z-1205-2026)Philips North America2026-01-29
Ingenia 1.5T. Product Code (REF): (1) 781341, (2) 781396. MR systems with SW version R11.1 recall (Z-1206-2026)Philips North America2026-01-29
Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with SW version R11.1 recall (Z-1207-2026)Philips North America2026-01-29
Ingenia 3.0T CX. Product Code (REF): 781271. MR systems with SW version R11.1 and R12.1. recall (Z-1208-2026)Philips North America2026-01-29
Ingenia Ambition S. Product Code (REF): 782108. MR systems with SW version R11.1 and R12.1 recall (Z-1209-2026)Philips North America2026-01-29
Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. MR systems with recall (Z-1210-2026)Philips North America2026-01-29
Ingenia Elition S. Product Code (REF): (1) 781357, (2) 782106, (3)782137. MR systems with recall (Z-1211-2026)Philips North America2026-01-29
Ingenia Elition X. Product Code (REF): (1) 781358, (2) 782107, (3) 782136. MR systems with recall (Z-1212-2026)Philips North America2026-01-29
MR 7700. Product Code (REF): (1) 782120, (2) 782153. MR systems with SW version R11.1 and recall (Z-1213-2026)Philips North America2026-01-29
Upgrade to MR 7700. Product Code (REF): 782130. MR systems with SW version R11.1 and R12.1 recall (Z-1214-2026)Philips North America2026-01-29
SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with SW version R11. recall (Z-1215-2026)Philips North America2026-01-29
SmartPath to dStream for XR and 3.0T. Product Code (REF): 781270. MR systems with SW versi recall (Z-1216-2026)Philips North America2026-01-29
Patient Information Center iX; Software Version Number: 4.5.0 recall (Z-1156-2026)Philips North America2026-01-22
Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSC recall (Z-0597-2026)Philips North America2025-12-09
Cardiac Workstation 5000; Model Number: 860439; recall (Z-0165-2026)Philips North America2025-10-16
Cardiac Workstation 7000; Model Number: 860441; recall (Z-0166-2026)Philips North America2025-10-16
Achieva 3.0T; Model Numbers (REF): (1) 781177, (2) 781277, (3) 781278, (4) 781344, (5) 781 recall (Z-2200-2025)Philips North America2025-07-30
Achieva XR; Model Numbers (REF): (1) 781153, (2) 781253; recall (Z-2201-2025)Philips North America2025-07-30
Evolution Upgrade 1.5T Model Numbers (REF): (1) 782116, (2) 782148; recall (Z-2202-2025)Philips North America2025-07-30
Evolution Upgrade 3.0T Model Numbers (REF): (1) 782117, (2) 782143; recall (Z-2203-2025)Philips North America2025-07-30
Ingenia 1.5T Model Numbers (REF): (1) 781315, (2) 718641, (3) 781396, (4) 782101, (5) 7821 recall (Z-2204-2025)Philips North America2025-07-30
Ingenia 1.5T S Model Number (REF): 781347; recall (Z-2205-2025)Philips North America2025-07-30
Ingenia 3.0T Model Numbers (REF): (1) 781342, (2) 781377, (3) 782103; recall (Z-2206-2025)Philips North America2025-07-30
Ingenia 3.0T CX Model Numbers (REF): (1) 781271, (2) 782105; recall (Z-2207-2025)Philips North America2025-07-30
Ingenia Ambition S Model Numbers (REF): (1) 781359, (2) 782108, (3) 782133 (China ONLY), ( recall (Z-2208-2025)Philips North America2025-07-30
Ingenia Ambition X Model Numbers (REF): (1) 781356, (2) 782109, (3) 782138; recall (Z-2209-2025)Philips North America2025-07-30
Ingenia Elition S Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (4) 782150 (Chi recall (Z-2210-2025)Philips North America2025-07-30
Ingenia Elition X Model Numbers (REF): (1) 781358, (2) 782107, (3) 782119, (4) 782136, (5) recall (Z-2211-2025)Philips North America2025-07-30
Intera 3.0T Quasar Dual Model Number (REF): 781150; recall (Z-2212-2025)Philips North America2025-07-30
MR 5300 Model Numbers (REF): (1) 782110, (2) 782135 (China ONLY), (3) 782152; recall (Z-2213-2025)Philips North America2025-07-30
MR 7700 Model Numbers (REF): (1) 782120, (2) 782153; recall (Z-2214-2025)Philips North America2025-07-30
SmartPath to dStream for 3.0T Model Number (REF): 782145; recall (Z-2215-2025)Philips North America2025-07-30
SmartPath to dStream for XR and 3.0T Model Numbers (REF): (1) 781270, (2) 782113, (3) 7821 recall (Z-2216-2025)Philips North America2025-07-30
SmartPath to Ingenia Elition X Model Numbers (REF): (1) 782118, (2) 782144; recall (Z-2217-2025)Philips North America2025-07-30
Upgrade to MR 7700 Model Number (REF): 782130; recall (Z-2218-2025)Philips North America2025-07-30
Achieva XR Product Numbers: (1) 781153, (2) 781253; recall (Z-1928-2025)Philips North America2025-06-09
Intera 1.5T Achieva IT Nova Product Number: 781175 recall (Z-1929-2025)Philips North America2025-06-09
Intera 1.5T Achieva Nova Product Number: 781172; recall (Z-1930-2025)Philips North America2025-06-09
Intera 1.5T Achieva Nova-Dual Product Number: 781173; recall (Z-1931-2025)Philips North America2025-06-09
Intera 1.5T Explorer/Nova Dual Product Number: 781108; recall (Z-1932-2025)Philips North America2025-06-09
Intera 1.5T Master/Nova Product Number: 781106; recall (Z-1933-2025)Philips North America2025-06-09
Intera 1.5T Omni/Stellar; Product Number: 781104; recall (Z-1934-2025)Philips North America2025-06-09
Intera Achieva 1.5T Pulsar; Product Number: 781171; recall (Z-1935-2025)Philips North America2025-06-09
SmartPath to dStream for 1.5T; Product Number: 782146; recall (Z-1936-2025)Philips North America2025-06-09
Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expa recall (Z-0035-2025)Philips North America2024-10-08
IntelliVue G7m Anesthesia Gas Module, Product Number 866173 recall (Z-0007-2025)Philips North America2024-10-01
BV Endura, BV Pulsera Philips Image Guided Therapy-Systems (IGTS)Mobile Surgery C-arm syst recall (Z-0224-2024)Philips North America2024-09-30
Zenition 50 & 70 Mobile Surgery C-arm recall (Z-0226-2024)Philips North America2024-09-30
Integris-Allura IGTS Fixed Systems recall (Z-0227-2024)Philips North America2024-09-30
Allura Xper IGTS Fixed Systems recall (Z-0228-2024)Philips North America2024-09-30
Azurion IGTS Fixed Systems recall (Z-0229-2024)Philips North America2024-09-30
Veradius Unity Mobile Surgery C-arm recall (Z-0230-2024)Philips North America2024-09-30
IntelliVue Patient Monitor MX400 (Model Number 866060), MX430 (Model Number 866061), MX450 recall (Z-3249-2024)Philips North America2024-09-25
PHILIPS Incisive Computed tomography X-ray system Incisive CT Software Upgrade from V4.5.1 recall (Z-1507-2024)Philips North America2024-04-09
Patient Information Center iX (PIC iX), Model Numbers 866389, 866390 (PIC iX Expand), and recall (Z-1386-2024)Philips North America2024-03-27
CareEvent Event Management System, Model Numbers 866435 and 866436 (CareEvent Upgrade), So recall (Z-1387-2024)Philips North America2024-03-27
ProxiDiagnost N90- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref recall (Z-1072-2024)Philips North America2024-02-09
ProxiDiagnost upgrade- A Multi-functional general Radiography and Fluoroscopy (R/F) system recall (Z-1073-2024)Philips North America2024-02-09
BrightView, gamma camera system; Model Nos.: 6-digit format 882480; 12-digit format 453560 recall (Z-0929-2024)Philips North America2024-02-02
BrightView X, gamma camera for SPECT; Model Nos.: 6-digit format 882478; 12-digit format 4 recall (Z-0930-2024)Philips North America2024-02-02
BrightView XCT, gamma camera for SPECT; Model Nos.: 6-digit format 882482; 12-digit format recall (Z-0931-2024)Philips North America2024-02-02
Ingenia 1.5T (Product Number 781396) - HA FlexTrak II (Accessory Number 989710008732), pat recall (Z-0973-2024)Philips North America2024-02-02
Ingenia Elition X (Product Number 781358) - HA FlexTrak II (Accessory Number 989710008732) recall (Z-0974-2024)Philips North America2024-02-02
Ingenia Ambition X (Product Number 781356) - HA FlexTrak II (Accessory Number 989710008732 recall (Z-0975-2024)Philips North America2024-02-02
Achieva 1.5T. Model (REF) Numbers 781196, 781343, 781296. recall (Z-0945-2024)Philips North America2024-02-01
Achieva 1.5T Conversion. Model (REF) Numbers 781346, 781283. recall (Z-0946-2024)Philips North America2024-02-01
Achieva 1.5T Initial system. Model (REF) Numbers 781178. recall (Z-0947-2024)Philips North America2024-02-01
Achieva 3.0T. Model. (REF) Numbers 781277, 781177, 781278, 781344, 781345. recall (Z-0948-2024)Philips North America2024-02-01
Achieva XR. Model (REF) Numbers 781153, 781253. recall (Z-0949-2024)Philips North America2024-02-01
Ingenia 1.5T CX. Model (REF) Numbers 781262, 781261. recall (Z-0950-2024)Philips North America2024-02-01
Ingenia 3.0T CX. Model (REF) Numbers 781271, 782105. recall (Z-0951-2024)Philips North America2024-02-01
Intera 1.5T Achieva Nova. Model (REF) Numbers 781172. recall (Z-0952-2024)Philips North America2024-02-01
Intera 1.5T Achieva Nova-Dual. Model (REF) Number 781173. recall (Z-0953-2024)Philips North America2024-02-01
Intera Achieva 1.5T Pulsar. Model (REF) Number 781171. recall (Z-0954-2024)Philips North America2024-02-01
SmartPath to dStream for 1.5T. Model (REF) Numbers 781260, 782112. recall (Z-0955-2024)Philips North America2024-02-01
SmartPath to dStream for XR and 3.0T. Model (REF) Numbers 781270, 782113, 782129. recall (Z-0956-2024)Philips North America2024-02-01
Achieva 1.5T, Model No. 781178, 781196, 781296 recall (Z-0807-2024)Philips North America2024-01-25
Achieva 1.5T Conversion, Model No. 781283 recall (Z-0808-2024)Philips North America2024-01-25
Achieva 3.0T, Model No. 781177 recall (Z-0809-2024)Philips North America2024-01-25
Ingenia Ambition X, Model No. 782109 recall (Z-0810-2024)Philips North America2024-01-25
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