—#130372

Product

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 for bedside examinations.

FDA product code: KPR — System, X-Ray, Stationary
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K111292
Affected lot / code info: Siemens Luminos Agile Max system material #s: 10762472, with serial numbers: 61013 61015 61011 61014 61017

Why it was recalled

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 (FDA determination)

Software design

Action the firm took

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 610-219-2119 or 610-219-4834. For questions regarding this recall call 610-219-6300.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution - US including UT, MO, CO, MA, MN, MS, OH, SC, MI, and NY.

Timeline

Recall initiated: 2014-09-02
Posted by FDA: 2014-10-02
Terminated: 2015-02-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #130372. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.