Siemens Medical Solutions USA, Inc. Siemens, ACUSON Antares, Ultrasound System (Standard and Premium Edition), 5.0 Systems with software version 200.0.054, P/N : 10032747 and 10032746 standard, 10032746, 10037591, and 10038202 for premium edition, Siemens, Ultrasound Division, Mountain View, CA 94039 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Siemens, ACUSON Antares, Ultrasound System (Standard and Premium Edition), 5.0 Systems with software version 200.0.054, P/N : 10032747 and 10032746 standard, 10032746, 10037591, and 10038202 for premium edition, Siemens, Ultrasound Division, Mountain View, CA 94039
Brand
Siemens Medical Solutions USA, Inc.
Lot Codes / Batch Numbers
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Products Sold
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Siemens Medical Solutions USA, Inc. is recalling Siemens, ACUSON Antares, Ultrasound System (Standard and Premium Edition), 5.0 Systems with software due to Image errors: A software problem results in on-screen indications (graphics) that lead the user to believe that the patient's right and left and the t. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Image errors: A software problem results in on-screen indications (graphics) that lead the user to believe that the patient's right and left and the transducer orientation are oriented the same. This is not the case and the actual patient's right and left are reversed from the on-screen indicators.
Recommended Action
Per FDA guidance
The firm sent a recall letter, Urgent Medical Device Notification, to consignees on 07/10/2007, to be followed by a service visit by Siemens personnel for a mandatory software update to be installed. Short term the users were instructed to avoid increasing the SieClear compounding levels to an Advanced SieClear compounding setting after an L/R invert action with Biopsy guidelines on-screen.
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 noticePage updated: Jan 10, 2026