Recalls / —

—#73819

Product

Axiom Aristos FX Multipurpose Radiography System, stationary X-Ray system, Model number: 7414803.

FDA product code

KPR — System, X-Ray, Stationary

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K013826

Affected lot / code info

Serial numbers: 1059, 1078, 1083, 1088, 1093, 1109, and 1135.

Why it was recalled

Tube support arm or the detecting mounting hardware may become loose at the joint with the telescope.

Root cause (FDA determination)

Equipment maintenance

Action the firm took

Updated Instructions were issued in August 2008 (AX049/08/S) to Siemens Service Engineers to have them inspect and tighten any loose hardware on the affected systems.

Recalling firm

Firm

Siemens Medical Solutions USA, Inc

Address

51 Valley Stream Pkwy, Malvern, Pennsylvania 19355-1406

Distribution

Distribution pattern

Nationwide distribution including states of CA, IN, KY, UT, VA and WI.

Timeline

Recall initiated

2008-08-25

Posted by FDA

2008-10-20

Terminated

2008-10-20

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #73819. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.