Siemens Medical Solutions USA, Inc Breast Biopsy Aiming Device. Magnetic Resonance Imaging System. Model number 5728735 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Breast Biopsy Aiming Device. Magnetic Resonance Imaging System. Model number 5728735
Brand
Siemens Medical Solutions USA, Inc
Lot Codes / Batch Numbers
Model number 5728735
Products Sold
Model number 5728735
Siemens Medical Solutions USA, Inc is recalling Breast Biopsy Aiming Device. Magnetic Resonance Imaging System. Model number 5728735 due to 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 . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, FL, IL, IN, MD, MN, NM, OH, OR, RI, WI
Page updated: Jan 10, 2026