—#132119

Product

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 intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The Ysio Max system is not meant for mammography. The Ysio Max uses integrated or portable digital detectors for generating diagnostic images by converting x-rays into electronic signals. Ysio Max is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.

FDA product code: KPR — System, X-Ray, Stationary
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K062623, K111292, K133259
Affected lot / code info: Material 10762470 10762470 10762470 10762470 10762470 10762470 10762470 10762470 10762470 10762470 10762470 serial numbers24077 24051 24038 24059 24066 24015 24026 24058 24039 24090 24075

Why it was recalled

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 (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355-1406

Distribution

Distribution pattern: US Distribution to states of: ID, IL, MI, MN, MO, ND and PA.

Timeline

Recall initiated: 2014-12-15
Posted by FDA: 2015-01-16
Terminated: 2017-01-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #132119. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.