Date Initiated by Firm | June 12, 2019 |
Create Date | July 22, 2019 |
Recall Status1 |
Terminated 3 on September 18, 2020 |
Recall Number | Z-2016-2019 |
Recall Event ID |
83203 |
510(K)Number | K052202 |
Product Classification |
Interventional fluoroscopic x-ray system - Product Code OWB
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Product | AXIOM Artis BA, Model Number 5904656 |
Code Information |
Serial Numbers: 28159 28144 28154 28139 28155 28160 28156 |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 40 Liberty Blvd Malvern PA 19355-1418
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For Additional Information Contact | Meredith Adams 610-219-4834 |
Manufacturer Reason for Recall | A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure. |
FDA Determined Cause 2 | Component design/selection |
Action | Urgent Medical Device Correction notification letters dated 6/12/19 were sent to customers.
In the event the issue occurs, the system cannot be operated normally as X-ray will not possible. Planned procedures may have to be terminated and performed on an alternative X-ray system. Siemens advises that an alternative system is available to continue treatment in case of occurrence.
Siemens is implementing a corrective action to all potentially affected users of the Artis Zee and AXIOM Artis systems with generator A100 via Update Instruction AX038/18/S. The Siemens Service organization will modify the affected supply circuit and revise the wiring. This modification will bring the voltage back to the center of the tolerance range.
Our service organization will contact you shortly to arrange a date to perform this corrective action. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436. Following the correction, the cause is eliminated and any recurrence of this potential fault is prevented. |
Quantity in Commerce | 7 |
Distribution | US Nationwide Distribution |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = OWB
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