Date Initiated by Firm | September 03, 2013 |
Date Posted | November 27, 2013 |
Recall Status1 |
Terminated 3 on March 09, 2015 |
Recall Number | Z-0140-2014 |
Recall Event ID |
66314 |
510(K)Number | K062623 K101491 |
Product Classification |
System, x-ray, fluoroscopic, image-intensified - Product Code JAA
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Product | Siemens RAD Fluoro Uro system (Luminos dRF and Uroskop Omnia with software version VD10A/G
Image intensified Fluoroscopic X-ray system |
Code Information |
Model numbers 10094910 and 10094200 with software version VD10A/G. |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 51 Valley Stream Pkwy Malvern PA 19355
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For Additional Information Contact | Customer Support 610-219-6300 |
Manufacturer Reason for Recall | When using systems operating with software versions VD10A/G during a RAD examination, a malfunction can result in radiation continuing longer than required resulting in an overexposed image that is not of diagnostic quality, prompting repetition of the examination. |
FDA Determined Cause 2 | Software design |
Action | Siemens sent an Field Safety Notice dated September 3, 2013, to all affected customers.The letter identified the product the problem and the action to be taken by the customer.
Action to be taken:
1. It is not possible for the user to prevent this malfunction. The exposure time with the use of automatic exposure control is limited to 500ms, which is the maximum duration of radiation in this mode. The exposure can be interrupted by the user at anytime by releasing the exposure button.
2. There are two possibilities to solve this issue:
a.) Switch off the system if the message "wait for FLC" in status bar does not disappear approximately. 30s after the OGP selection. The system gets ready after switching the system on and reselecting the Torno OGP.
b.) Press Shift+F10. The pop up message has to be confirmed and you have to wait approximately.
40s until! the "i" icon in the status bar stops blinking. After that a RAD OGP has to be selected and then the Torno OGP. Thereafter, the system gets ready.
3. It is not possible for the user to prevent this malfunction
The Center for Devices and Radiological Health (CDRH) understands that your
Corrective Action Plan (CAP) will involve 59 units and consist of the following elements:
1. You have notified affected customers with Field Safety Notice XP032/13/S.
2. You have prepared a field modification of the Luminos dRF and Uroskop Omnia
systems with software version VD10A/G.
3. Distribution of this field modification will began in September 2013 as Update
Instruction XP015/13/S at no cost to the user.
For further Customer Support call (610) 219-6300. |
Quantity in Commerce | 59 |
Distribution | Worldwide Distribution - USA (nationwide) and Internationally to Canada. |
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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