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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall AXIOM SIRESKOP SD, SIRESKOP SX, AXIOM LUMINOS see related information
Date Initiated by Firm January 14, 2011
Date Posted February 23, 2011
Recall Status1 Terminated 3 on July 16, 2013
Recall Number Z-1421-2011
Recall Event ID 57775
510(K)Number K051602  K951358  K062623  
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 2		 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 and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
510(K)s with Product Code = MQB and Original Applicant = SIEMENS MEDICAL SYSTEMS, INC.
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