Alphenix INFX-8000C/B5
FDA Recall Z-0108-2027 · Posted 2026-10-07
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Recalling FirmCanon Medical System, USA, INC.
Recall StatusOpen, Classified
Product CodeOWB
Date Initiated2026-08-26
Product Quantity1 unit
Reason for Recall
Loosening of the bolts securing the longitudinal movement mechanism may cause the tabletop to shift, resulting in [positional/imaging/patient] misalignment and a longitudinal motion error
Firm Action
On August 26, 2026, Canon Medical Systems USA, Inc. issued a Urgent: Medical Device Correction notification to affected consignees via mail. Canon ask consignees to take the following actions:
1. Should this problem occur before inspection of the tightening of the bolt(s) is implemented on your system, please stop using the device and call your service representative.
2. Additionally, it is strongly requested that you share the contents of this letter with all users as well as clinical engineering or biomedical group at your facility.
3. A representative of Canon Medical Systems USA will contact you to schedule a time to inspect the tightening and properly fixing of the bolt(s) to correct this issue with your system(s).
4. If you have any questions regarding this matter, please contact your service representative contact our InTouch team at (800) 521-1968 or by email at [email protected].
5. Canon respectfully requests that the attached form be completed and returned via email to [email protected].
Root Cause
Process control
Distribution Pattern
US Nationwide distribution in the state of ID.
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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