Class 2 Device Recall AXIOM SIRESKOP SD, SIRESKOP SX, AXIOM LUMINOS

• Date Initiated by Firm: January 14, 2011
• Date Posted: February 23, 2011
• Recall Status: Terminated on July 16, 2013
• Recall Number: Z-1421-2011
• Recall Event ID: 57775
• 510(K)Number: K051602 K062623 K951358
• Product Classification: Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
• Product: AXIOM SIRESKOP SD, SIRESKOP SX, AXIOM LUMINOS System, X-Ray, Fluoroscopic, image-intensified; solid state x-ray imager (flat panel/digital imager)
• Code Information: Model Numbers: 3111668, 3111676, 8890407, 8890415, and 10093902
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 51 Valley Stream Pkwy; Malvern PA 19355
• For Additional Information Contact: Meredith Adams; 610-448-3237
• Manufacturer Reason for Recall: Firm became aware of a potential malfunction and possible hazard to patients in the event the tilt buttons on the OPTI Grip become stuck under the housing
• FDA Determined Cause: Other
• Action: Siemens Medical Solutions USA, Inc issued a Customer Safety Advisory Notice via Update Instruction XP005/10/S to affected customers. This letter informs customers of the potential malfunction and of possible danger for patients, users or other persons. A future Update Instruction will be released for the replacement of the tilt buttons on all OPTI Grip handles. Customers were instructed to forward the safety notice to any new owners of this device and to provide Siemens Medical with names of the new customers. For any questions regarding this recall call 610-448-3237.
• Quantity in Commerce: 1323
• Distribution: Nationwide Distribution including AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MQB; 510(K)s with Product Code = MQB