Recall Z-1159-2012 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Siemens Medical Solutions USA, Inc
Siemens Ysio, AXIOM Luminos dRF, AXIOM Luminos Agile/TF, Uroskop Omnia Solid state x-ray imager (flat panel/digital imager)
| Date | Mar 5, 2012 (initiated Feb 15, 2012) |
| Status | Terminated |
| Reason | Firm has become aware of unintended behavior when using Ysio, AXIOM dRF, AXIOM Luminos Agile/TF and Uroskop Omnia with RAD Fluoro Uro function using software version VC10A. Due to an error in the image pipeline, images may display dark and not suitable for diagnostic. Due to this software error customers have to repeat x-ray exposure to receive diagnostic images. |
| Root cause | Software design |
| Action | Siemens sent Update Instruction XP057/11/S by mail on February 15, 2012, which releases software update package VC10D to remedy the described issues. For questions regarding this recall call 610-219-4834. |
| Quantity | 58 |
| Distribution | Nationwide Distribution including AK, CA, CO, FL, GA, IL, IN, IA, KY, MD, MA, MO, NE, NY, NC, OH, OR, PA, SC, TX, and UT. |
| FDA record | Open on fda.gov |