Date Initiated by Firm | January 08, 2020 |
Create Date | August 05, 2020 |
Recall Status1 |
Terminated 3 on June 21, 2022 |
Recall Number | Z-2755-2020 |
Recall Event ID |
85999 |
510(K)Number | K173639 |
Product Classification |
System, x-ray, fluoroscopic, image-intensified - Product Code JAA
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Product | SIEMENS Healthineers Luminos dRF Max
Model: 10762471- Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. |
Code Information |
Serial Numbers: 5043 5085 5825 5234 5862 5751 5340 5810 5188 5352 5719 5803 5812 5920 5921 5209 5069 5086 5151 5299 5372 5611 5037 5072 5947 5049 5190 5892 5961 5364 5163 5919 5355 5902 5690 5767 5954 5954 5884 5278 5963 5956 5682 5953 5634 5951 5120 5962 |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 40 Liberty Blvd Malvern PA 19355
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For Additional Information Contact | SAME 610-219-4834 |
Manufacturer Reason for Recall | Two software issues (1) Using the override function in case of blocked system movements affecting Luminos dRF Max, Luminos Agile Max and Uroskop Omnia Max systems may cause collision of the system under operator control with obstacles or persons .(2) Incorrectly assigned image affecting Ysio Max, Luminos dRF Max and Luminos Agile Max systems with detector MAX Static causing incorrect base for diagnosis |
FDA Determined Cause 2 | Device Design |
Action | Siemens Medical Solutions USA, Inc. has initiated a Customer Safety Advisory Notice to all affected customers via XP028/19/S January 2020. Additionally, a solution to eliminate the root cause of this problem is being distributed via XP008/20/S March 2020. Following the corrective action, the cause is eliminated and a recurrence of the fault is prevented.
New corrective software VE10Y became available June 22, 2020, and it is being distributed via an Update Instruction XP008/20/S. This update fixes the initial reported issue and the sporadic image loss issue noted by customers who had already installed VE10W (XP029/19/S).
The original Customer Safety Advisory Notice (XP028/19/S) and the information letter distributed in March 2020 remain applicable.
This resolution will be provided free of charge. Your local Siemens Healthineers Service organization will contact you to arrange a date to perform this corrective action . Questions contact the service organization for an earlier appointment at 1-800-888-7436 |
Quantity in Commerce | 49 units |
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 = JAA
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