Siemens Medical Solutions USA, Inc.: ACUSON SC2000 volume imaging ultrasound systems at software versions VA16C, VA16D and VA16E. Model 10433816. Product Usage: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. Typical examination performed using the SC2000 Ultrasound System are: Cardiac Imaging Applications and Analysis; Vascular Imaging Applications and Analysis; Superficial Imaging Applications; Intraoperative Imaging Applications; Transcranial Imaging Applications;

Recall number

Z-1581-2015

Recalling firm

Siemens Medical Solutions USA, Inc.

Product

ACUSON SC2000 volume imaging ultrasound systems at software versions VA16C, VA16D and VA16E. Model 10433816. Product Usage: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. Typical examination performed using the SC2000 Ultrasound System are: Cardiac Imaging Applications and Analysis; Vascular Imaging Applications and Analysis; Superficial Imaging Applications; Intraoperative Imaging Applications; Transcranial Imaging Applications;

Status

Terminated

Initiated

2012-05-11

Posted

2015-05-05

Terminated

2015-05-06

Reason

In some cases, the system is unable to capture a clip or image during a routine scan.

Root cause

Other

Action

Siemens sent a Customer Advisory Notice letter to affected customers. The letter identified the affected product. problem and how this issue is being resolved. To resolve this issue on all affected systems, a mandatory software update has been developed and is being installed free of charge.

Quantity

186 devices

Distribution

Worldwide Distribution - US Nationwide and the countries of:Angola, Armenia, Australia, Austria, Belgium, Bosnia Herzeg., Brazil, Brunei, Bulgaria, Colombia, Czech Republic, Finland, France, Germany, India, Japan, Kazakhstan, Kenya, Kuwait, Mauritius, Mexico, Norway, Oman, P.R. China, Poland, Rep. of Yemen, Republic Korea, Romania, Russian Fed., Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, U.A.E., United Kingdom.

Lot, serial or model codes

Model 10433816, software versions VA16C, VA16D and VA16E. Device serial numbers:  400230 400708 400462 400467 400460 400461 400084 451021 400743 400225 450122 400634 400687 400023 400126 400265 400717 400740 400458 400459 400678 400665 450123 400617 400485 400083 400092 451024 400223 400404 450143 400650 400663 400664 400577 400470 400479 400493 400519 400318 400674 400463 400484 400679 400680 400589 400466 400168 400139 400270 400308 400236 400689 400691 450151 400693 400615.

510(k) numbers

["K123622"]

PMA numbers

not on file

Product code

IYO

Firm FEI

2936884

Firm city

Mountain View

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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