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

FDA device recall Z-1959-2011 · posted 2011-04-12 · Terminated

Recall details

Recalling firm

Siemens Medical Solutions USA, Inc

Reason for recall

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

Action taken

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.

Root cause

Other

Status

Terminated

Product code

KPR

Quantity affected

101

Distribution

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.

Date initiated

2011-02-17

Date posted

2011-04-12

Date terminated

2013-07-16

Location

Malvern, PA

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