Z-0138-06

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

Name: Z-0138-06 Breast Biopsy Aiming Device. Magnetic Resonance Imaging System. Model number 5728735
Creator: Siemens Medical Solutions USA, Inc
Published: 2005-10-05
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2005-10-05 / Terminated

FDA source

Siemens Medical Solutions USA, Inc began a recall of Breast Biopsy Aiming Device. Magnetic Resonance Imaging System. Model number 5728735 on 2005-10-05. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0138-06
Status: Terminated
Initiated: 2005-10-05
Posted: 2005-11-15
Terminated: 2007-08-07
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Breast Biopsy Aiming Device. Magnetic Resonance Imaging System. Model number 5728735
Product code: LNH System, Nuclear Magnetic Resonance Imaging
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
FDA root cause: Other
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.
Quantity in commerce: 16 units
Distribution: The product was shipped to medical facilities in CA, FL, IL, MD, MN, NM, OH, OR, RI, and WI.
Product codes and lots: Model number 5728735

Product code LNH

K010773Class IIBreast Biopsy Device/magnetom SystemsSiemens Medical Solutions USA, Inc. / cleared 2001-05-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)