—#66619

Product

Magnetom Espree with Swiveling OR (Operating Room) Table, Magnetic Resonance Imaging System,Siemens Medical Solutions USA, Inc., Malvern, PA

FDA product code: LNH — System, Nuclear Magnetic Resonance Imaging
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K041112
Affected lot / code info: Serial Numbers 1002, 1003, 1004, and 1007

Why it was recalled

Table may experience a deadlock situation

Root cause (FDA determination)

Software design

Action the firm took

The recalling firm issued a Customer Safety Advisory to affected customers per Update Instructions MR031/07/S. The letter informs customers of the potential issue and provides instructions to avoid its occurrence. The recalling firm has also released the software update to correct the issue via Update Instructions MR034/07/S. Notifications were issued on or about November 5, 2007.

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 TX and NY.

Timeline

Recall initiated: 2007-11-05
Posted by FDA: 2008-02-05
Terminated: 2008-02-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #66619. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.