| Ingenia Elition X- For use as a diagnostic device to obtain cross-sectional images, spectr recall (Z-3200-2024) | Philips North America Llc | 2024-09-20 |
| MR 5300 - For use as a diagnostic device to obtain cross-sectional images, spectroscopic i recall (Z-3201-2024) | Philips North America Llc | 2024-09-20 |
| MR 7700 -For use as a diagnostic device to obtain cross-sectional images, spectroscopic im recall (Z-3202-2024) | Philips North America Llc | 2024-09-20 |
| SmartPath to dStream for 1.5T - For use as a diagnostic device to obtain cross-sectional i recall (Z-3203-2024) | Philips North America Llc | 2024-09-20 |
| SmartPath to dStream for XR and 3.0T- For use as a diagnostic device to obtain cross-secti recall (Z-3204-2024) | Philips North America Llc | 2024-09-20 |
| SmartPath to Ingenia Elition X - For use as a diagnostic device to obtain cross-sectional recall (Z-3205-2024) | Philips North America Llc | 2024-09-20 |
| IntelliVue Patient Monitor MX400 with L.x and M.x; K.x provided with L.x entitlements Mode recall (Z-2508-2024) | Philips North America Llc | 2024-08-05 |
| IntelliVue Patient Monitor MX450 with L.x and M.x; K.x provided with L.x entitlements Mode recall (Z-2509-2024) | Philips North America Llc | 2024-08-05 |
| IntelliVue Patient Monitor MX500 with L.x and M.x; K.x provided with L.x entitlements Mode recall (Z-2510-2024) | Philips North America Llc | 2024-08-05 |
| IntelliVue Patient Monitor MX550 with L.x and M.x; K.x provided with L.x entitlements Mode recall (Z-2511-2024) | Philips North America Llc | 2024-08-05 |
| Avalon Ultrasound Transducer. Directs low-energy ultrasound beam toward the fetal heart an recall (Z-2239-2024) | Philips North America Llc | 2024-06-28 |
| SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Ph recall (Z-2163-2024) | Philips North America Llc | 2024-06-27 |
| SENSE XL TORSO COIL 3.0T. 16-element receive only coil for torso and abdomen imaging in Ph recall (Z-2164-2024) | Philips North America Llc | 2024-06-27 |
| SENSE XL TORSO COIL 1.5T Mk2. 16-element receive only coil for torso and abdomen imaging i recall (Z-2165-2024) | Philips North America Llc | 2024-06-27 |
| HA FlexTrak-Patient transport functionality to transport the patient from the preparation recall (Z-1948-2024) | Philips North America Llc | 2024-06-04 |
| HA FlexTrak-Patient transport functionality to transport the patient from the preparation recall (Z-1949-2024) | Philips North America Llc | 2024-06-04 |
| HA FlexTrak II-Patient transport functionality to transport the patient from the preparati recall (Z-1950-2024) | Philips North America Llc | 2024-06-04 |
| Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images recall (Z-1871-2024) | Philips North America Llc | 2024-05-20 |
| Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images recall (Z-1872-2024) | Philips North America Llc | 2024-05-20 |
| Achieva 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for recall (Z-1836-2024) | Philips North America Llc | 2024-05-17 |
| Achieva 1.5T Conversion- Magnetic Resonance (MR) systems are Medical Electrical Systems in recall (Z-1837-2024) | Philips North America Llc | 2024-05-17 |
| Achieva 1.5T Initial system Model Number (REF): 781178 recall (Z-1838-2024) | Philips North America Llc | 2024-05-17 |
| Achieva 3.0T Model Number (REF): (1) 781345; (2) 781344; (3) 781278; (4) 781277; (5) 78117 recall (Z-1839-2024) | Philips North America Llc | 2024-05-17 |
| Achieva 3.0T for PET -Magnetic Resonance (MR) systems are Medical Electrical Systems indic recall (Z-1840-2024) | Philips North America Llc | 2024-05-17 |
| Achieva 3.0T TX for PET Model Number (REF): 781479 recall (Z-1841-2024) | Philips North America Llc | 2024-05-17 |
| AchievaXR -Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for us recall (Z-1842-2024) | Philips North America Llc | 2024-05-17 |
| Evolution upgrade 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems ind recall (Z-1843-2024) | Philips North America Llc | 2024-05-17 |
| Evolution upgrade 3.0T Model Number (REF): (1)782117; (2) 782143 recall (Z-1844-2024) | Philips North America Llc | 2024-05-17 |
| Ingenia 1.5T Model Number (REF): (1) 782140; (2) 782115; (3) 782101; (4) 781396; (5) 78134 recall (Z-1845-2024) | Philips North America Llc | 2024-05-17 |
| Ingenia 1.5T CX - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated recall (Z-1846-2024) | Philips North America Llc | 2024-05-17 |
| Ingenia 1.5T S Model Number (REF): 781347 recall (Z-1847-2024) | Philips North America Llc | 2024-05-17 |
| Ingenia 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for recall (Z-1848-2024) | Philips North America Llc | 2024-05-17 |
| Ingenia 3.0T CX Model Number (REF): (1) 782105 (2) 781271 recall (Z-1849-2024) | Philips North America Llc | 2024-05-17 |
| Ingenia Ambition S Model Number (REF): (1) 782139; (2) 782133; (3) 782108; (4) 781359 recall (Z-1850-2024) | Philips North America Llc | 2024-05-17 |
| Ingenia Ambition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicat recall (Z-1851-2024) | Philips North America Llc | 2024-05-17 |
| Ingenia Elition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicate recall (Z-1852-2024) | Philips North America Llc | 2024-05-17 |
| Intera 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for recall (Z-1853-2024) | Philips North America Llc | 2024-05-17 |
| MR 5300- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use recall (Z-1854-2024) | Philips North America Llc | 2024-05-17 |
| Panorama HFO- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for recall (Z-1855-2024) | Philips North America Llc | 2024-05-17 |
| Marlin 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for recall (Z-1856-2024) | Philips North America Llc | 2024-05-17 |
| MR system 1.5T Marlin- Magnetic Resonance (MR) systems are Medical Electrical Systems indi recall (Z-1857-2024) | Philips North America Llc | 2024-05-17 |
| MR RT - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use a recall (Z-1858-2024) | Philips North America Llc | 2024-05-17 |
| MR RT Upgrades- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated f recall (Z-1859-2024) | Philips North America Llc | 2024-05-17 |
| SmartPath to dStream for 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Syst recall (Z-1860-2024) | Philips North America Llc | 2024-05-17 |
| SmartPath to dStream for 3.0T Model Number (REF): 782145 recall (Z-1861-2024) | Philips North America Llc | 2024-05-17 |
| SmartPath to dStream for XR and 3.0T- Magnetic Resonance (MR) systems are Medical Electric recall (Z-1862-2024) | Philips North America Llc | 2024-05-17 |
| SmartPath to Ingenia Elition X - Magnetic Resonance (MR) systems are Medical Electrical Sy recall (Z-1863-2024) | Philips North America Llc | 2024-05-17 |
| Sonalleve MR HIFU 3.0T - Magnetic Resonance (MR) systems are Medical Electrical Systems in recall (Z-1864-2024) | Philips North America Llc | 2024-05-17 |
| Upgrade dStream - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated recall (Z-1865-2024) | Philips North America Llc | 2024-05-17 |
| Patient Information Center iX and Patient Information Center iX Expand, Software Version 4 recall (Z-1827-2024) | Philips North America Llc | 2024-05-15 |
| Ingenia 1.5T with Evolution Upgrade 1.5T - Magnetic Resonance (MR) systems are Medical Ele recall (Z-1829-2024) | Philips North America Llc | 2024-05-15 |
| Ingenia 3.0T with Evolution Upgrade 3.0T - - Magnetic Resonance (MR) systems are Medical E recall (Z-1830-2024) | Philips North America Llc | 2024-05-15 |
| The Oncology Essentials Package of the Spectral CT imaging system. recall (Z-1756-2024) | Philips North America Llc | 2024-05-02 |
| Philips Patient Information Center (PIC) iX Uninterruptable Power Supply (UPS): 1. APC (Sc recall (Z-1690-2024) | Philips North America Llc | 2024-04-25 |
| Achieva 1.5T, Magnetic Resonance System. recall (Z-1550-2024) | Philips North America Llc | 2024-04-17 |
| Achieva 1.5T Conversion, Magnetic Resonance System. recall (Z-1551-2024) | Philips North America Llc | 2024-04-17 |
| Achieva 1.5T Initial, Magnetic Resonance System. recall (Z-1552-2024) | Philips North America Llc | 2024-04-17 |
| Achieva 3.0T, Magnetic Resonance System. recall (Z-1553-2024) | Philips North America Llc | 2024-04-17 |
| Achieva 3.0T for PET, Magnetic Resonance System. recall (Z-1554-2024) | Philips North America Llc | 2024-04-17 |
| Achieva 3.0TX for PET, Magnetic Resonance System. recall (Z-1555-2024) | Philips North America Llc | 2024-04-17 |
| Achieva XR, Magnetic Resonance System. recall (Z-1556-2024) | Philips North America Llc | 2024-04-17 |
| Enterprise 1.5T, Magnetic Resonance System. recall (Z-1557-2024) | Philips North America Llc | 2024-04-17 |
| Evolution Upgrade 3.0T, Magnetic Resonance System. recall (Z-1558-2024) | Philips North America Llc | 2024-04-17 |
| GYROSCAN ACS-NT, Magnetic Resonance System. recall (Z-1559-2024) | Philips North America Llc | 2024-04-17 |
| GYROSCAN T10-NT, Magnetic Resonance System. recall (Z-1560-2024) | Philips North America Llc | 2024-04-17 |
| GYROSCAN T5, Magnetic Resonance System. recall (Z-1561-2024) | Philips North America Llc | 2024-04-17 |
| GYROSCAN T5-NT, Magnetic Resonance System. recall (Z-1562-2024) | Philips North America Llc | 2024-04-17 |
| Ingenia 1.5T, Magnetic Resonance System. recall (Z-1563-2024) | Philips North America Llc | 2024-04-17 |
| Ingenia 1.5T CX, Magnetic Resonance System. recall (Z-1564-2024) | Philips North America Llc | 2024-04-17 |
| Ingenia 1.5T S, Magnetic Resonance System. recall (Z-1565-2024) | Philips North America Llc | 2024-04-17 |
| Ingenia 3.0T, Magnetic Resonance System. recall (Z-1566-2024) | Philips North America Llc | 2024-04-17 |
| Ingenia 3.0T CX, Magnetic Resonance System. recall (Z-1567-2024) | Philips North America Llc | 2024-04-17 |
| Ingenia Ambition S, Magnetic Resonance System. recall (Z-1568-2024) | Philips North America Llc | 2024-04-17 |
| Ingenia Ambition X, Magnetic Resonance System. recall (Z-1569-2024) | Philips North America Llc | 2024-04-17 |
| Ingenia Elition S, Magnetic Resonance System. recall (Z-1570-2024) | Philips North America Llc | 2024-04-17 |
| Ingenia Elition X, Magnetic Resonance System. recall (Z-1571-2024) | Philips North America Llc | 2024-04-17 |
| Intera 0.5T Standard, Magnetic Resonance System. recall (Z-1572-2024) | Philips North America Llc | 2024-04-17 |
| Intera 1.0T Omni/Stellar, Magnetic Resonance System. recall (Z-1573-2024) | Philips North America Llc | 2024-04-17 |
| Intera 1.0T Power/Pulsar, Magnetic Resonance System. recall (Z-1574-2024) | Philips North America Llc | 2024-04-17 |
| Intera 1.5T, Magnetic Resonance System. recall (Z-1575-2024) | Philips North America Llc | 2024-04-17 |
| Intera 1.5T Achieva IT Nova, Magnetic Resonance System. recall (Z-1576-2024) | Philips North America Llc | 2024-04-17 |
| Intera 1.5T Achieva Nova, Magnetic Resonance System. recall (Z-1577-2024) | Philips North America Llc | 2024-04-17 |
| Intera 1.5T Achieva Nova-Dual, Magnetic Resonance System. recall (Z-1578-2024) | Philips North America Llc | 2024-04-17 |
| Intera 1.5T Explorer/Nova Dual, Magnetic Resonance System. recall (Z-1579-2024) | Philips North America Llc | 2024-04-17 |
| Intera 1.5T Master/Nova, Magnetic Resonance System. recall (Z-1580-2024) | Philips North America Llc | 2024-04-17 |
| Intera 1.5T Omni/Stellar, Magnetic Resonance System. recall (Z-1581-2024) | Philips North America Llc | 2024-04-17 |
| Intera 1.5T Power/Pulsar, Magnetic Resonance System. recall (Z-1582-2024) | Philips North America Llc | 2024-04-17 |
| Intera 1.5T R11, Magnetic Resonance System. recall (Z-1583-2024) | Philips North America Llc | 2024-04-17 |
| Intera 3.0T Quasar Dual, Magnetic Resonance System. recall (Z-1584-2024) | Philips North America Llc | 2024-04-17 |
| Intera Achieva 1.5T Pulsar, Magnetic Resonance System. recall (Z-1585-2024) | Philips North America Llc | 2024-04-17 |
| Intera CV, Magnetic Resonance System. recall (Z-1586-2024) | Philips North America Llc | 2024-04-17 |
| MR 5300, Magnetic Resonance System. recall (Z-1587-2024) | Philips North America Llc | 2024-04-17 |
| MR 7700, Magnetic Resonance System. recall (Z-1588-2024) | Philips North America Llc | 2024-04-17 |
| SmartPath to dStream for 1.5T, Magnetic Resonance System. recall (Z-1589-2024) | Philips North America Llc | 2024-04-17 |
| SmartPath to dStream for XR and 3.0T, Magnetic Resonance System. recall (Z-1590-2024) | Philips North America Llc | 2024-04-17 |
| Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System. recall (Z-0725-2024) | Philips North America Llc | 2024-01-12 |
| The device is a whole-body CT x-ray system. The acquired x-ray transmission data is recons recall (Z-0576-2024) | Philips North America Llc | 2023-12-18 |
| Panorama 1.0T HFO, Magnetic Resonance (MR) System; Model Numbers 781250 and 781350. Philip recall (Z-0505-2024) | Philips North America Llc | 2023-12-14 |
| Achieva 1.5T recall (Z-0389-2024) | Philips North America Llc | 2023-11-21 |
| Achieva 1.5T Conversion recall (Z-0390-2024) | Philips North America Llc | 2023-11-21 |