Recall Z-0140-2014 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Siemens Medical Solutions USA, Inc
Siemens RAD Fluoro Uro system (Luminos dRF and Uroskop Omnia with software version VD10A/G Image intensified Fluoroscopic X-ray system
| Date | Nov 27, 2013 (initiated Sep 3, 2013) |
| Status | Terminated |
| Reason | 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 | 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 FL |
| Quantity | 59 |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to Canada. |
| FDA record | Open on fda.gov |