Recalls / —

—#34883

Product

Siregraph CF X-Ray System. Fluoroscopic image intensified. Model number 4466033

FDA product code

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

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K960266

Affected lot / code info

Serial numbers: 1506, 1528, 1529, 1539, 1544, 1568, 1572, 1633, 1821, 1841, 1864, 1877, 2020, 2023, and 2126.

Why it was recalled

X-ray tube movement when table is tilted more than 90 degrees

Root cause (FDA determination)

Other

Action the firm took

The recalling firm issued a Customer DAfety Advisory letter dated 6/7/04 to the hospitals. The letter informs them of the potential problem and provides preventative measures to avoid its occurance.

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 medical facilities in FL, IL, MI, NH, NJ, PA, and TX.

Timeline

Recall initiated

2004-06-07

Posted by FDA

2004-09-18

Terminated

2005-08-18

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #34883. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.