Philips Medical Systems North America Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 5
- 510(k) Clearances
- 95
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1264-2014 | Class II | Philips Model EPIQ 7 Ultrasound System. Intended for diagnostic ultrasound imaging and fluid flow a | February 28, 2014 |
| Z-1263-2014 | Class II | Philips Model EPIQ 5 Ultrasound System. Intended for diagnostic ultrasound imaging and fluid flow a | February 28, 2014 |
| Z-1225-2014 | Class II | Philips HeartStart FR3 Automated External Defibrillator (AED), models 861388 and 861389. The Hear | February 6, 2014 |
| Z-1232-2014 | Class II | Philips HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs). Product Usage | February 6, 2014 |
| Z-0368-2014 | Class II | EPIQ 7 Ultrasound System, Model 795200, 795201, 795202. Intended for diagnostic ultrasound imagin | October 17, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K101311 | EP NAVIGATOR R3 | September 30, 2010 |
| K102005 | ALLURA XPER OR TABLE SERIES | August 9, 2010 |
| K090625 | WIRELESS PORTABLE DETECTOR FD-W17 | March 24, 2009 |
| K090590 | VERADIUS, MODEL 718-130 | March 16, 2009 |
| K082280 | SURESIGNS VS2 VITAL SIGNS MONITOR, SURESIGNS VM1 PATIENT MONITOR, SURESIGNS VS3 CITAL SIGNS MONITOR | October 8, 2008 |
| K063781 | PHILIPS XD-S DIRECT RADIOGRAPHY WORKSTATION/PACKAGE | January 5, 2007 |
| K062233 | HEARTSTART MRX MONITOR/DEFIBRILLATOR | November 22, 2006 |
| K062268 | MASIMO SET SPO2 MODULE FOR PHILIPS AND M3001A MULTI-MEASUREMENT SERVER OPTION A03 | October 18, 2006 |
| K062283 | THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 INTELLIVUE PATIENT MONITORS | September 20, 2006 |
| K061685 | PULSERA | September 15, 2006 |
| K061995 | XCELERA | September 6, 2006 |
| K061052 | THE PHILIPS INTELLIVUE PATIENT MONITORS, MODELS MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90 | May 26, 2006 |
| K060749 | XPERCT | April 4, 2006 |
| K050692 | FLXIS | April 8, 2005 |
| K043147 | ACHIEVA FAMILY | February 15, 2005 |
| K050151 | MULTIDIAGNOST ELEVA | February 9, 2005 |
| K042867 | PHILIPS ORTHOPAEDIC APPLICATIONS | November 2, 2004 |
| K042368 | PRACTIX CONVENIO | October 4, 2004 |
| K042334 | ALLURA 3D-CA, RELEASE 1 | September 27, 2004 |
| K041949 | ALLURA XPER FD10 | July 30, 2004 |