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U.S. Department of Health and Human Services

Class 2 Device Recall ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM

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 Class 2 Device Recall ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEMsee related information
Date Initiated by FirmOctober 12, 2026
Date PostedOctober 27, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0290-2027
Recall Event ID 99889
510(K)NumberK182415 
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
ProductALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM REF: INFX-8000F
Code Information DI-04987670100208/
FEI Number 2020563
Recalling Firm/
Manufacturer		 Canon Medical System, USA, INC.
2441 Michelle Dr
Tustin CA 92780-7047
For Additional Information ContactCanon InTouch
800-521-1968
Manufacturer Reason
for Recall		Due to software issue, X-ray interventional system may experience internal error if F-Store or imagine acquisition is performed while clinical analysis function is use.
FDA Determined
Cause 2		Software design
ActionOn October 12, 2026, Canon Medical Systems USA, Inc. issued a Urgent: Medical Device Correction to affected consignees. Canon provided the following to consignees: 1. A representative of Canon Medical Systems USA will contact you to schedule a time to conduct installation of modified software to prevent internal errors from occuring if F-STORE or image acquisition is performed while CAAS clinical analysis function is used. 2. If you have any questions regarding this matter, please contact your service representative or contact our InTouch team at (800) 521-1968 or by email intouchdispatch@us.medical.canon. 3. In order to comply with the FDA record keeping requirement, Canon respectfully requests that the attached form be completed and returned via email to fieldcorrections@us.medical.canon
Quantity in Commerce3 units
DistributionUS Nationwide distribution in the states of AL, AR, AZ, CA, FL, GA, HI, IL, LA, MA, MI, MN, MS, NC, NV, OH, OR, TX.
Total Product Life CycleTPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = OWB
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