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Class 2 Device Recall Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax |
![see related information](../images/related-info.gif) |
Date Initiated by Firm |
December 09, 2022 |
Date Posted |
January 20, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1002-2023 |
Recall Event ID |
91383 |
510(K)Number |
K173639
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Product Classification |
Interventional fluoroscopic x-ray system - Product Code OWB
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Product |
Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max |
Code Information |
All serial numbers
1) Luminos Agile Max, Material #10762472, UDI/DI: 4056869009162
2) Luminos drF Max, Material #10762471, UDI/DI: 4056869009155
3) Luminos Lotus Max, Material #11574100, UDI/DI: 4056869269331 |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 40 Liberty Blvd Malvern PA 19355-1418
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For Additional Information Contact |
Rebecca Tudor 610-219-4834
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Manufacturer Reason for Recall |
There is potential for the footrest to detach from the patient table during use.
Device intended to visualize anatomical structures by converting an Xray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract. The unit may also be used in emergency applications, lymphography, endoscopy, myelography, venography, arthrography, interventional radiology, digital angiography, and digital subtraction angiography (DSA). The system may be used on pediatric, adult, and bariatric patients. These devices are not for mammography examinations.
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FDA Determined Cause 2 |
Process control |
Action |
A Customer Safety Advisory Notification (CSAN) was distributed to affected consignees beginning December 9, 2022. The CSAN was distributed to inform the customers about a preventative measure to exclude any potential risk of patient injury caused by the footrest detaching from the patient table during examination. Together with the CSAN, an addendum to the operator manual is distributed containing additional details and illustrations on how to securely attach the footrest to further improve the understanding of handling the footrest. Refer to the CSAN with addendum and copies of the Instructions for Use for each reported system. |
Quantity in Commerce |
886 units |
Distribution |
Worldwide 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database |
510(K)s with Product Code = OWB and Original Applicant = Siemens Medical Solutions, Inc
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