—#42746

Product

Breast Biopsy Aiming Device. Magnetic Resonance Imaging System. Model number 5728735

FDA product code: LNH — System, Nuclear Magnetic Resonance Imaging
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K010773
Affected lot / code info: Model number 5728735

Why it was recalled

If the recommended workflow is not followed and the worksheets are printed after moving the patient table out of isocenter, the offset values will be incorrect. This could result in a biopsy being performed at an incorrect location and presents the possibility of an inconclusive diagnosis. calculation of offset values for the breast biopsy aiming device may be incorrect

Root cause (FDA determination)

Other

Action the firm took

The recalling firm issued a Customer Safety Advisory via certified mail to affected customers per Update Instructions MR034/05/S. The letter re-emphasizes the importance of printing the offset values on the worksheet prior to moving the patient table and in accordance with the User's Manual.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355-1406

Distribution

Distribution pattern: The product was shipped to medical facilities in CA, FL, IL, MD, MN, NM, OH, OR, RI, and WI.

Timeline

Recall initiated: 2005-10-05
Posted by FDA: 2005-11-15
Terminated: 2007-08-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #42746. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.