—#107662

Product

Siemens Ysio, AXIOM Luminos dRF, AXIOM Luminos Agile/TF, Uroskop Omnia Solid state x-ray imager (flat panel/digital imager)

FDA product code: MQB — Solid State X-Ray Imager (Flat Panel/Digital Imager)
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K062623, K081722, K101491, K111292
Affected lot / code info: Model numbers 10281013, 10094200, 10502200, 10094910

Why it was recalled

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 (FDA determination)

Software design

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2012-02-15
Posted by FDA: 2012-03-05
Terminated: 2014-01-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #107662. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.