Ysio Max, Luminos dRF Max and Agile Max systems with software version VE10 and SmartOrtho license. The Ysio Max is a rad
FDA device recall Z-0994-2015 · posted 2015-01-16 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Potential for composed images to be flipped before being sent to PACS on systems with software version VE10 and SmartOrtho license. Flipped images may be reversed so the associated annotations, e.g. labels (R/L), may be displayed incorrectly, potentially leading to misdiagnosis.
- Action taken
- The firm, Siemens, sent a "Safety Advisory Notice - XP080/14/S" letter dated December 8, 2014, to end users that identified the product, problem, and actions to be taken. Siemens provided instructions to avoid the issue and indicated a software fix would be released as a permanent resolution. The customers were instructed observe this safety notice and comply with the corresponding measure until the update has been fully completed. If you have any questions, contact the Regulatory Technical Specialist at 610-219-2119.
- Root cause
- Software design
- Status
- Terminated
- Product code
- KPR
- Quantity affected
- 11
- Distribution
- US Distribution to states of: ID, IL, MI, MN, MO, ND and PA.
- Date initiated
- 2014-12-15
- Date posted
- 2015-01-16
- Date terminated
- 2017-01-26
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| YSIO MAX (K133259) | Siemens Medical Solutions USA, Inc. | 2014-01-24 |
| LUMINOS AGILE (K111292) | Siemens Medical Solutions USA, Inc. | 2011-06-03 |
| AXIOM LUMINOS DRF (K062623) | Siemens Medical Solutions USA, Inc. | 2007-08-22 |