Recalls / —

—#88790

Product

Axiom Iconos R200 X-Ray

FDA product code

JAA — System, X-Ray, Fluoroscopic, Image-Intensified

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K992660

Affected lot / code info

Model numbers 10093961, 5902767, 5902775, 5902783, 5902791, 5904086, 7152460, and 7152478

Why it was recalled

table can tilt/move when it is not intended

Root cause (FDA determination)

Software design

Action the firm took

The recalling firm has issued a letter to affected customers and will send technicians to apply the fix to each defective device.

Recalling firm

Firm

Siemens Medical Solutions USA, Inc

Address

51 Valley Stream Pkwy, Malvern, Pennsylvania 19355

Distribution

Distribution pattern

Nationwide Distribution.

Timeline

Recall initiated

2010-01-29

Posted by FDA

2010-03-27

Terminated

2010-08-11

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #88790. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.