Recalls / —

—#106477

Product

Siemens AXIOM Aristos FX Plus solid state x-ray imager. Image-intensified fluoroscopic x-ray system.

FDA product code

MQB — Solid State X-Ray Imager (Flat Panel/Digital Imager)

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K061054

Affected lot / code info

Serial number 1273

Why it was recalled

Fixation bolts for the mounting of the X-ray tube holder became mixed with an incorrect bolt type.

Root cause (FDA determination)

Process control

Action the firm took

Siemens Healthcare sent a "SAFETY ADVISORY NOTICE" dated December 12, 2011 to the affected customer. The letter identifies the product, problem, and actions to be taken by the customer. The firm prepared a modification, which will be provided to the affected customer under Update Instruction XP055/11/S. The firm will resolve this potential issue by preventively exchanging all bolts for the fixation of the X-ray tube holder of the concerned AXIOM Aristos FX Plus unit.

Recalling firm

Firm

Siemens Medical Solutions USA, Inc

Address

51 Valley Stream Pkwy, Malvern, Pennsylvania 19355

Distribution

Distribution pattern

Product distributed in one hospital in California.

Timeline

Recall initiated

2011-12-12

Posted by FDA

2012-01-25

Terminated

2014-01-14

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #106477. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.