—#98367

Product

Axiom Aristos FX and FX Plus System Intended use: Stationary x-ray system

FDA product code: KPR — System, X-Ray, Stationary
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K013826, K061054
Affected lot / code info: Model numbers 10093864 and 7414803 -- Serial numbers up to and including 1216.

Why it was recalled

During product monitoring, firm discovered a possible hazard to patients when using the detector alpha rotation of all Axiom Aristos FX and FX Plus systems with serial numbers up to and including 1216. When using the detector alpha rotation, the detector may descend unexpectedly during movement or in vertical or table mode. If this occurs in vertical modes, the possibility exists that the detect

Root cause (FDA determination)

Other

Action the firm took

The firm, SIEMENS, sent a "Safety Advisory Notice" dated February 15, 2011 to the affected customers via Update Instructions XP016/10/S on February 17, 2011. The notice described the product, problem and actions to be taken. The customers were instructed to immediately instruct their personnel accordingly; ensure that the safety advisory is placed in the systems's instructions for use; if they have sold this device/equipment and it is no longer in their possession, forward this safety notice to the new owner of the device/equipment; inform SIEMENS about the new owner of the device/equipment, and complete and return the Acknowledgement of receipt form. SIEMENS is preparing a modification of AXIOM Aristos FX and FX Plus that will resolve this potential malfunction. The field modification will be available from February 2011 and is expected to be carried out May 31, 2011. If you have any questions, call 09131-18-9908 or +1-888-826-9702.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution: USA including states of: AZ, AK, CA, CO, FL, GA. IL, IN, IA, KS, KY, ME, MI, MN, MS, MO, NE, NV, NJ, NY, NC, OH, OR, PA, SC, TN, TX, UT, VA, and WI.

Timeline

Recall initiated: 2011-02-17
Posted by FDA: 2011-04-12
Terminated: 2013-07-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #98367. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.