AXIOM SIRESKOP SD, SIRESKOP SX, AXIOM LUMINOS System, X-Ray, Fluoroscopic, image-intensified; solid state x-ray imager (

FDA device recall Z-1421-2011 · posted 2011-02-23 · Terminated

Recall details

Recalling firm

Siemens Medical Solutions USA, Inc

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

Action taken

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

Status

Terminated

Product code

MQB

Quantity affected

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

Date initiated

2011-01-14

Date posted

2011-02-23

Date terminated

2013-07-16

Location

Malvern, PA

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