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.
Recall
- Recall Number
- Z-0549-2021
- Event Number
- 86864
- Firm
- Canon Medical System, USA, INC.
- FEI Number
- 2020563
- Product Code
- JAK
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- November 9, 2020
- Terminated
- December 16, 2022
- Address
- 2441 Michelle Dr, Tustin, CA, 92780-7047
Description
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.
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.
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 engineering or biomedical group at your facility. 3. If you have any questions, please feel free to contact Terry Schultz Regulatory Affairs Manager at (800) 421-1968 or your local Canon service representative at (800) 521-1968.
US Nationwide distribution. OUS: Unknown
60 units