Recall Z-0994-2015 ยท KPR System, X-Ray, Stationary
Siemens Medical Solutions USA, Inc
Ysio Max, Luminos dRF Max and Agile Max systems with software version VE10 and SmartOrtho license. The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for int
| Date | Jan 16, 2015 (initiated Dec 15, 2014) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | 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. |
| Quantity | 11 |
| Distribution | US Distribution to states of: ID, IL, MI, MN, MO, ND and PA. |
| FDA record | Open on fda.gov |