Philips Medical Systems (Cleveland) Inc
FDA Regulatory Profile
Philips Medical Systems (Cleveland) Inc appears in FDA public data with 315 recalls — including 5 Class I (most serious) —, 190 510(k) clearances, 13 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-2570-2025, Class II) was initiated on August 5, 2025. Its most recent 510(k) clearance was granted on November 9, 2017.
Summary
- Total Recalls
- 315 (5 Class I)
- 510(k) Clearances
- 190
- Inspections
- 13
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2570-2025 | Class II | Pinnacle Radiation Therapy Planning System: Multimodality Simulation Workspace 18.0.5 Model 87025 | August 5, 2025 |
| Z-2239-2025 | Class II | Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software | July 17, 2025 |
| Z-1744-2022 | Class II | Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237. | August 30, 2022 |
| Z-0214-2020 | Class I | Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of sin | September 19, 2019 |
| Z-0217-2020 | Class I | Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of sin | September 19, 2019 |
| Z-0215-2020 | Class I | Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of sin | September 19, 2019 |
| Z-0213-2020 | Class I | Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of sin | September 19, 2019 |
| Z-0216-2020 | Class I | Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of sin | September 19, 2019 |
| Z-2189-2019 | Class II | iCT, Model # 728306, computed tomography x-ray system | June 24, 2019 |
| Z-2193-2019 | Class II | Ingenuity TF PET/CT Model # 882456, computed tomography x-ray system | June 24, 2019 |
| Z-2190-2019 | Class II | iCT SP Model # 728311, computed tomography x-ray system | June 24, 2019 |
| Z-2188-2019 | Class II | Ingenuity Core Model # 728321, computed tomography x-ray system | June 24, 2019 |
| Z-2192-2019 | Class II | IQon Spectral CT Model # 728332, computed tomography x-ray system | June 24, 2019 |
| Z-2186-2019 | Class II | Ingenuity CT, Model # 728326, computed tomography x-ray system | June 24, 2019 |
| Z-2191-2019 | Class II | Brilliance 64 Model # 728231, computed tomography x-ray system | June 24, 2019 |
| Z-2187-2019 | Class II | Ingenuity Core128 Model # 728323, computed tomography x-ray system | June 24, 2019 |
| Z-2194-2019 | Class II | Vereos PET/CT Model # 882446, computed tomography x-ray system | June 24, 2019 |
| Z-2011-2019 | Class II | BrightView XCT , Model Number 882482 | June 10, 2019 |
| Z-2010-2019 | Class II | BrightView X , Model Number 882478 | June 10, 2019 |
| Z-2009-2019 | Class II | BrightView SPECT, Model Number 882480 | June 10, 2019 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K171850 | Philips CT Big Bore | November 9, 2017 |
| K172406 | Ingenuity TF | October 6, 2017 |
| K162838 | Philips iCT CT System | April 7, 2017 |
| K163711 | IQon Spectral CT | April 5, 2017 |
| K170086 | Pinnacle Radiation Therapy Planning System | February 9, 2017 |
| K160743 | Philips Ingenuity CT | August 8, 2016 |
| K153444 | Philips Multislice CT System with Low Dose CT Lung Cancer | April 8, 2016 |
| K130992 | PINNACLE3 RADIATION THERAPY PLANNING SYSTEM | June 14, 2013 |
| K111336 | EBW NM 2.0 | May 24, 2011 |
| K111024 | JETPACK 2.0 | April 21, 2011 |
| K092747 | PHILIPS COMPREHENSIVE CARDIAC ANALYSIS (CCA) - PLAQUE ASSESSMENT TOOL | October 9, 2009 |
| K090462 | BRILLIANCE DUAL ENERGY OPTION | June 23, 2009 |
| K091195 | PHILIPS MX 16 SLICE CT SYSTEM PHASE11, MODEL 9896 056 56511 | May 27, 2009 |
| K090403 | AUTOSPECT | March 31, 2009 |
| K083498 | PHILIPS MODEL MX 16 SLICE CT SYSTEM | December 17, 2008 |
| K081426 | NEXSTAR LIFTOFF PET APPLICATION SOFTWARE SUITE | June 4, 2008 |
| K081135 | GEMINI CONDOR | April 29, 2008 |
| K080927 | BRIGHTVIEW VCT IMAGING SYSTEM | April 11, 2008 |
| K060937 | BRILLIANCE VOLUME | June 5, 2006 |
| K052640 | GEMINI RAPTOR | October 7, 2005 |