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.
FDA Recall Z-0549-2021 · Posted None
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Recalling FirmCanon Medical System, USA, INC.
Recall StatusTerminated
Product CodeJAK
Date Initiated2020-11-09
Date Terminated2022-12-16
Product Quantity60 units
Reason for Recall
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.
Firm 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 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.
Root Cause
Software design
Distribution Pattern
US Nationwide distribution. OUS: Unknown
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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