Recall Z-0005-2015 ยท KPR System, X-Ray, Stationary
Siemens Medical Solutions USA, Inc
Siemens Luminos Agile Max system The Luminos Agile is intended to be used as a universal imaging system for radiographic and fluoroscopic studies. Using either film cassettes or a digital mobile flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. Luminos Agile is applicable to emergency treatment on an outpatient basis, as well as f
| Date | Oct 2, 2014 (initiated Sep 2, 2014) |
| Status | Terminated |
| Reason | Two malfunctions posing potential risk to patients were identified with Siemens Ysio Max, AXIOM Luminos dRF Max, Uroskop Omnia Max, and Luminos Agile Max systems with a specific set of serial numbers that will cause lost images due to an automatic Radiology Information System (RIS) worklist update, thus causing examinations to be repeated. Image label may also be displayed incorrectly after images |
| Root cause | Software design |
| Action | Siemens sent a Safety Advisory Notice, dated September 2, 2014, to all affected customers. The Notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to disable the automatic RIS worklist update and perform this procedure manually. Customers should disable the Measurement Field Display and Collimator Display by setting the display time for both setting to 0 sec (if editable). Customers should forward the safety notice to the new owner and inform Siemens of the new owner where possible. Customers with questions should call 610-21 |
| Quantity | 5 |
| Distribution | Nationwide Distribution - US including UT, MO, CO, MA, MN, MS, OH, SC, MI, and NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111292 | LUMINOS AGILE Siemens Medical Solutions USA, Inc., Jun 3, 2011 |