FDA Medical Device Recalls (openFDA)
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)
- Recall number
- Z-1159-2012
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Siemens Ysio, AXIOM Luminos dRF, AXIOM Luminos Agile/TF, Uroskop Omnia Solid state x-ray imager (flat panel/digital imager)
- Status
- Terminated
- Initiated
- 2012-02-15
- Posted
- 2012-03-05
- Terminated
- 2014-01-14
- 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.
- Lot, serial or model codes
- Model numbers 10281013, 10094200, 10502200, 10094910
- 510(k) numbers
- ["K062623","K081722","K101491","K111292"]
- PMA numbers
- not on file
- Product code
- MQB
- Firm FEI
- 2240869
- Firm city
- Malvern
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28