| Date Initiated by Firm | August 26, 2026 |
|---|
| Date Posted | October 07, 2026 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0108-2027 |
|---|
| Recall Event ID |
99817 |
| 510(K)Number | K210900 |
|---|
| Product Classification |
Interventional fluoroscopic x-ray system - Product Code OWB
|
| Product | Alphenix INFX-8000C/B5 |
|---|
| Code Information |
Serial no. B5F2532011/UDI: 4987670100192 |
| FEI Number |
2020563
|
Recalling Firm/
Manufacturer |
Canon Medical System, USA, INC.
2441 Michelle Dr
Tustin
CA
92780-7047
|
| For Additional Information Contact | Orlando Tadeo
714-730-5000 |
|---|
Manufacturer 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 |
|---|
FDA Determined
Cause 2 | Process control |
|---|
| 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 intouchdispatch@us.medical.canon.
5. Canon respectfully requests that the attached form be completed and returned via email to fieldcorrections@us.medical.canon. |
|---|
| Quantity in Commerce | 1 unit |
|---|
| Distribution | US Nationwide distribution in the state of ID. |
|---|
| 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 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) Database | 510(K)s with Product Code = OWB
|
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