Recall Z-0549-2021 ยท JAK System, X-Ray, Tomography, Computed
Canon Medical System, USA, INC.
Canon Aquilion Prime SP, Multislice Helical CT Scanner, TSX-303B/8L - Product Usage: intended to acquire and display cross-sectional volumes of the whole body, including the head.
| Date | Nov 9, 2020 |
| Status | Terminated |
| Reason | A software problem has been identified which could result in the CT Scanner not proceeding to the next actual scan even though automatic start of the next scan is specified. This could result in the CT scan failing resulting in rescanning and reinjection of contrast medium. |
| Root cause | Software design |
| Action | On 11/9/2020, Canon issued a "Urgent: Medical Device Correction" letter to all affected customers via facsimile. In addition, to informing consignees about the recall, the firm ask affected consignees to take the following actions: 1. Until corrective action has been taken, in order to avoid the problem, please use the system with setting InstaView OFF according to the last notification (dated June 2020) Subject: Abnormality in Realtime Reconstruction Images. Please see Attachment A. 2. Please share this information with all users and reviewing radiologists as well as the clinical engineerin |
| Quantity | 60 units |
| Distribution | US Nationwide distribution. OUS: Unknown |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K192832 | Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i Canon Medical Systems Corporation, Feb 21, 2020 |