Recalls / —

—#41294

Product

Arcadis Orbic Mobile X-Ray System

FDA product code

IZL — System, X-Ray, Mobile

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K040066

Affected lot / code info

Model number 8081080

Why it was recalled

Screws may become loose and fall into the OR field during surgery.

Root cause (FDA determination)

Other

Action the firm took

The recalling firm has their Service Engineers visiting each site to check the screws on the window and secure them with Loctite per Update Instructions SP022/05/S. The Service Engineer is also informing the account of the problem during the visits.

Recalling firm

Firm

Siemens Medical Solutions USA, Inc

Address

51 Valley Stream Pkwy, Malvern, Pennsylvania 19355-1406

Distribution

Distribution pattern

The products were shipped nationwide to a distributor, a physician, and medical facilities

Timeline

Recall initiated

2005-08-01

Posted by FDA

2005-11-02

Terminated

2006-07-19

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #41294. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.