Recalls / —

—#29022

Product

Urology X-Ray System, Uroskop D1/D2/D3 - Hardware for Motor Drive

FDA product code

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

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K923049

Affected lot / code info

Uroskop D1/D2/D3

Why it was recalled

possible movement of table tilt and table longitudinal

Root cause (FDA determination)

Other

Action the firm took

The recalling firm issued Update Instructions SP016/03/S, SP017/03S and SP018/03/S that instruct the Service Engineers to visit each affected system to install the required parts.

Recalling firm

Firm

Siemens Medical Solutions USA, Inc

Address

51 Valley Stream Parkway, Malvern, Pennsylvania 19355

Distribution

Distribution pattern

Nationwide. The product was shipped to medical facilities in CA, FL, GA, IL, MD, NC, NJ, NY, OK, PA, SC, TN, TX, VA, WI, and WV.

Timeline

Recall initiated

2003-08-08

Posted by FDA

2003-10-15

Terminated

2004-01-16

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #29022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.