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Terminated

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

FDA Recall Z-0138-06 · Posted 2005-11-15

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeLNH
Date Initiated2005-10-05
Date Terminated2007-08-07
Product Quantity16 units

Reason for Recall

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

Firm Action

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.

Root Cause

Other

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K010773BREAST BIOPSY DEVICE/MAGNETOM SYSTEMSSiemens Medical Solutions USA, Inc. · 2001-05-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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