Philips Medical Systems Gmbh, DMC
FDA Regulatory Profile
Philips Medical Systems Gmbh, DMC appears in FDA public data with 33 recalls, 1 510(k) clearance, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2357-2021, Class II) was initiated on July 22, 2020. Its most recent 510(k) clearance was granted on March 9, 2007.
Summary
- Total Recalls
- 33
- 510(k) Clearances
- 1
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2357-2021 | Class II | CombiDiagnost R90 Software Version R1.0 and R1.1 | July 22, 2020 |
| Z-1328-2020 | Class II | CombiDiagnost GCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, | December 19, 2019 |
| Z-1329-2020 | Class II | CombiDiagnost PCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, | December 19, 2019 |
| Z-0612-2019 | Class II | Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030 Stationary Fluoroscopic X-ra | November 7, 2018 |
| Z-0239-2019 | Class II | Philips DigitalDiagnost software 4.1.x and 4.2.x, A Stationary X-ray System Models: 712027, 712028, | September 19, 2018 |
| Z-2861-2018 | Class II | DigitalDiagnost Release 3 (Stitching Patient Support) 712025 | June 27, 2018 |
| Z-2862-2018 | Class II | DigitalDiagnost Release 3.1 (Stitching Patient Support) 712026 | June 27, 2018 |
| Z-2865-2018 | Class II | DigitalDiagnost, Dual-Detector (Stitching Patient Support) 712052 | June 27, 2018 |
| Z-2844-2018 | Class II | DigitalDiagnost Release 3 (Stitching Patient Support) 712025 | June 27, 2018 |
| Z-2868-2018 | Class II | EasyDiagnost Eleva DRF, Release 5 (Stitching Patient Support) 706050 | June 27, 2018 |
| Z-2859-2018 | Class II | DigitalDiagnost Dual Detector (Stitching Patient Support) 712022 | June 27, 2018 |
| Z-2853-2018 | Class II | DigitalDiagnost 4.1 Chest / Emergency (Stitching Patient Support) 712029 | June 27, 2018 |
| Z-2864-2018 | Class II | DigitalDiagnost Upgrades (Stitching Patient Support) 712083 | June 27, 2018 |
| Z-2842-2018 | Class II | DigitalDiagnost 4 Flex / Value (Stitching Patient Support) 712028 | June 27, 2018 |
| Z-2854-2018 | Class II | DigitalDiagnost 4.1 Flex / Value (Stitching Patient Support) 712028 | June 27, 2018 |
| Z-2852-2018 | Class II | DigitalDiagnost 4.1 (Stitching Patient Support) 712225 | June 27, 2018 |
| Z-2843-2018 | Class II | DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031 | June 27, 2018 |
| Z-2849-2018 | Class II | DigitalDiagnost 4 Chest / Emergency (Stitching Patient Support) 712029 | June 27, 2018 |
| Z-2841-2018 | Class II | DigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712082 | June 27, 2018 |
| Z-2863-2018 | Class II | DigitalDiagnost Single Detector (Stitching Patient Support) 712020 | June 27, 2018 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K070528 | PHILIPS ESSENTA DR | March 9, 2007 |