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U.S. Department of Health and Human Services

Class 2 Device Recall Canon PETCT SCANNER, Cartesion Prime

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  Class 2 Device Recall Canon PETCT SCANNER, Cartesion Prime see related information
Date Initiated by Firm November 11, 2020
Create Date October 19, 2021
Recall Status1 Terminated 3 on June 30, 2023
Recall Number Z-0142-2022
Recall Event ID 88691
510(K)Number K203314  
Product Classification System, tomography, computed, emission - Product Code KPS
Product Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A
Code Information Affected serial numbers: 3DA1982001, 3DA2072002, 3DA2072003
Recalling Firm/
Manufacturer		 Canon Medical System, USA, INC.
2441 Michelle Dr
Tustin CA 92780-7047
For Additional Information Contact Terry Schultz
714-730-5000
Manufacturer Reason
for Recall		 A software problem has been identified which could result in the diagnostic imaging system not proceeding to the next actual scan even though automatic start of the next scan is specified. This could result in the diagnostic imaging system failing resulting in rescanning and reinjection of contrast medium.
FDA Determined
Cause 2		 Software design
Action On November 11, 2020, Canon Medical Systems visited affected consignees and updated affected software. After completion of the software update, the consignee was provided a "Recall field Modification Instruction" document concerning the correction.
Quantity in Commerce 3 units
Distribution US Nationwide distribution in the states of NV, AR MN.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KPS and Original Applicant = Canon Medical Systems Corporation
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