| Date Initiated by Firm | October 20, 2021 |
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| Create Date | November 24, 2021 |
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| Recall Status1 |
Terminated 3 on June 18, 2024 |
| Recall Number | Z-0303-2022 |
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| Recall Event ID |
88962 |
| 510(K)Number | K181407 |
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| Product Classification |
Interventional fluoroscopic x-ray system - Product Code OWB
|
| Product | Artis Q.zen floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure
Model Number: 10848353 |
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| Code Information |
Serial Numbers: 105500 105503 105501 |
Recalling Firm/
Manufacturer |
Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
|
| For Additional Information Contact | SAME
610-219-4834 |
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Manufacturer Reason
for Recall | If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure |
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FDA Determined
Cause 2 | Software design |
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| Action | Siemens Medical Solutions USA, Inc. initiated a Customer Safety Advisory Notice dated 10/202/1 to customers via AX070/21/S, Siemens will update the system software via Update Instruction AX069/21/S. Letter states reason for recall, health risk and action to take:
To avoid the problem, it is recommended to position the SID first and then release x-ray.
Siemens will correct the software error (software VD12) via Update Instruction AX069/21/S. 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. We do not consider it necessary to re-examine any patients in relation to the issues described above.
Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Urgent Safety Advisory Notice. By signing this document, you are acknowledging that you have read and understand the content therein |
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| Quantity in Commerce | 3 units |
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| Distribution | US Nationwide Distribution |
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| 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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