Recalls / —

—#27955

Product

Axiom Aristos X-Ray System.

FDA product code

KPR — System, X-Ray, Stationary

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K013826

Affected lot / code info

part numbers 5895003 and 7414803. serial numbers 01001, 01170, 01219, 01221, and 01030.

Why it was recalled

software malfunction. May indicate that the image is flipped when it is not.

Root cause (FDA determination)

Other

Action the firm took

The recalling firm issued recall letters dated 4/19/03 to their accounts along with instructions for handling images that have already been archived.

Recalling firm

Firm

Siemens Medical Solutions USA, Inc

Address

51 Valley Stream Parkway, Malvern, Pennsylvania 19355

Distribution

Distribution pattern

The units were shipped to medical facilities nationwide.

Timeline

Recall initiated

2003-04-19

Posted by FDA

2003-07-08

Terminated

2004-08-25

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #27955. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.