—#41674

Product

Magnetom Espree. Magnetic Resonance Imaging System. model number 10018165

FDA product code: LNN
510(k) numbers: K041112
Affected lot / code info: Serial numbers 30001 to 30075

Why it was recalled

there is a misalignment of the patient table that may occur between the patient table and the opening to the magnet bore

Root cause (FDA determination)

Other

Action the firm took

The recalling firm issued via certified mail a Customer Safety Advisory to the affected customers per Update Instructions MR031/05/S. the letter informs customers of the potential issue and provides instructions to avoid its occurrence.

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 and MRI facilities nationwide.

Timeline

Recall initiated: 2005-08-12
Posted by FDA: 2005-09-09
Terminated: 2006-07-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #41674. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.