Siemens Ysio, AXIOM Luminos dRF, AXIOM Luminos Agile/TF, Uroskop Omnia Solid state x-ray imager (flat panel/digital imag
FDA device recall Z-1159-2012 · posted 2012-03-05 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MQB
- Quantity affected
- 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.
- Date initiated
- 2012-02-15
- Date posted
- 2012-03-05
- Date terminated
- 2014-01-14
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LUMINOS AGILE (K111292) | Siemens Medical Solutions USA, Inc. | 2011-06-03 |
| UROSKOP OMNIA (K101491) | Siemens Medical Solutions USA, Inc. | 2010-06-30 |
| YSIO (K081722) | Siemens Medical Solutions USA, Inc. | 2008-08-22 |
| AXIOM LUMINOS DRF (K062623) | Siemens Medical Solutions USA, Inc. | 2007-08-22 |