—#122033

Product

Siemens RAD Fluoro Uro system (Luminos dRF and Uroskop Omnia with software version VD10A/G Image intensified Fluoroscopic X-ray system

FDA product code: JAA — System, X-Ray, Fluoroscopic, Image-Intensified
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K062623, K101491
Affected lot / code info: Model numbers 10094910 and 10094200 with software version VD10A/G.

Why it was recalled

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.

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide) and Internationally to Canada.

Timeline

Recall initiated: 2013-09-03
Posted by FDA: 2013-11-27
Terminated: 2015-03-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #122033. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.