Toshiba American Medical Systems Inc
FDA Regulatory Profile
Summary
- Total Recalls
- 57
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2315-2018 | Class II | Diagnostic Ultrasound System, Aplio I-series. Labeled as i700, i800, i900 The power supply unit | January 4, 2018 |
| Z-0845-2018 | Class II | INFX-8000H Fluoroscopic X-Ray Systems | December 29, 2017 |
| Z-0842-2018 | Class II | INFX-8000F Fluoroscopic X-Ray Systems | December 29, 2017 |
| Z-0843-2018 | Class II | INFX-8000C Fluoroscopic X-Ray Systems | December 29, 2017 |
| Z-0844-2018 | Class II | INFX-8000V Fluoroscopic X-Ray Systems; INFINIX CF-I/BP PLUS CARDIAC SYSTEM | December 29, 2017 |
| Z-0012-2018 | Class II | Toshiba Medical Kalare Fluoroscopic X-Ray System (DREX-KL80) Kalare is intended to be used as | September 12, 2017 |
| Z-2710-2017 | Class II | APLIO 300 TUS-A300 diagnostic ultrasound system | May 1, 2017 |
| Z-2709-2017 | Class II | XARIO 200 TUS-X200 diagnostic ultrasound system | May 1, 2017 |
| Z-2712-2017 | Class II | APLIO i-series: a) APLIO i700 TUS AI700 b) APLIO i800 TUS AI800 diagnostic ultrasound system | May 1, 2017 |
| Z-2711-2017 | Class II | APLIO 500 TUS-A500 diagnostic ultrasound system | May 1, 2017 |
| Z-2708-2017 | Class II | XARIO 100 TUS-X100 diagnostic ultrasound system | May 1, 2017 |
| Z-3111-2017 | Class II | Toshiba Medical Radrex - i Digital Radiography X-ray system Radrex-i is intended for use in conju | March 23, 2017 |
| Z-3070-2017 | Class II | Toshiba America Medical Systems Ultimax Digital Fluoroscopic X-Ray System Model: DREX-UI80 Ultim | March 15, 2017 |
| Z-2109-2017 | Class II | Angio WorkStation (XIDF-AWS801) used in conjunction with your Infinix System (INFX-8000V;INFX-8000C; | February 1, 2017 |
| Z-0622-2017 | Class II | Aquilion Prime TSX-303A Aquilion PRIME is a multislice helical CT system with an 40-row detector. H | October 25, 2016 |
| Z-2542-2016 | Class II | Xario 100 Diagnostic Ultrasound System, TUS-X100; Xario 200 Diagnostic Ultrasound System, TUS-X200. | August 4, 2016 |
| Z-1398-2017 | Class II | Toshiba Ultimax DREX-ULT80 X-ray generator | May 19, 2016 |
| Z-1397-2017 | Class II | Toshiba Kalare DREX-KL80 X-ray generator | May 19, 2016 |
| Z-0047-2017 | Class II | Toshiba America Medical Systems, Inc . Aquilion RXL TSX-101 A/R, U CT Scanner Diagnostic imagin | April 25, 2016 |
| Z-0046-2017 | Class II | Toshiba America Medical Systems, Inc Aquilion Lightning TSX-035A CT Scanner. | April 25, 2016 |