Canon Aquilion One Vision, Model TSX-301C
FDA device recall Z-1722-2020 · posted 2020-04-10 · Open, Classified
Recall details
- Recalling firm
- Canon Medical System, USA, INC.
- Reason for recall
- Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off and reboot. Loss of the acquired raw data would occur.
- Action taken
- Recall letters dated 3/25/2019 were issued on 3/25/2019 via USPS return receipt mail.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- JAK
- Quantity affected
- 1 device
- Distribution
- Distribution was made to AK, AR, CA, FL, IA, ID, IL, KS, MA, MD, MI, MN, MO, MT, NC, ND, NH, NY, OH, OK, OR, PA, TN, TX, VT, WA, WI, and WV. There was government and military distribution but no forei
- Date initiated
- 2019-03-25
- Date posted
- 2020-04-10
- Location
- Tustin, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Aquilion ONE Vision with FIRST 1.0 (CCRS-001A) (K151673) | Toshibamedical Systems Corporation | 2015-11-27 |