AXIOM SIRESKOP SD, SIRESKOP SX, AXIOM LUMINOS System, X-Ray, Fluoroscopic, image-intensified; solid state x-ray imager (flat panel/digital imager)
FDA Recall Z-1421-2011 · Posted 2011-02-23
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Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeMQB
Date Initiated2011-01-14
Date Terminated2013-07-16
Product Quantity1323
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
Firm 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.
Root Cause
Other
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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