Recalls / —

—#43247

Product

3D TOP Ceiling Stand. X-Ray System model number 8773673

FDA product code

IYB — Tube Mount, X-Ray, Diagnostic

Device class

Class 1

Medical specialty

Radiology

510(k) numbers

K802200

Affected lot / code info

Model number 8773673

Why it was recalled

screws on the rollers may become loose

Root cause (FDA determination)

Other

Action the firm took

The recalling firm has issued a field correction per Update Instructions AX004/06/S. This update instructs a Siemens Customer Service Engineer to visit affected consignees and checkthe screws on the rollers. It also provides roller bearing sleeves as a secondary safety mechanism to prevent the rollers from detaching.

Recalling firm

Firm

Siemens Medical Solutions USA, Inc

Address

51 Valley Stream Pkwy, Malvern, Pennsylvania 19355-1406

Distribution

Distribution pattern

The products were shipped to hospitals and medical facilities nationwide.

Timeline

Recall initiated

2005-11-30

Posted by FDA

2005-12-31

Terminated

2006-07-19

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #43247. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.