Konica Minolta Medical Imaging USA, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 6
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2282-2018 | Class II | ImagePilot, Model No. D9MA | May 9, 2018 |
| Z-2281-2018 | Class II | CS-7, Model No. A4C1 | May 9, 2018 |
| Z-1212-2018 | Class II | Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A7AP, UDI: 04560141940031 | December 4, 2017 |
| Z-1215-2018 | Class II | Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A8AR, UDI: 04560141941588 | December 4, 2017 |
| Z-1213-2018 | Class II | Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A8WA, UDI: 04560141944534 | December 4, 2017 |
| Z-1214-2018 | Class II | Sonimage HS1 Ultrasound Kit AC adapter, Product Number: 1. A9RP, UDI: 04560141945463; 2. AAEU, UDI: | December 4, 2017 |