Siemens Medical Solutions USA, Inc.: Device Recall

Recall Details

Recall Number

Z-3217-2024

Classification

Class II

Product Type

Device

Recalling Firm

Siemens Medical Solutions USA, Inc.

Status

Ongoing

Date Initiated

08/15/2024

Location

Issaquah, WA, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

321

Reason for Recall

If ultrasound systems with software, are changed from factory default to : 1) Milliliters per second (ml/sec, mL/sec) or 2) Milliliters per minute (ml/min, mL/min); then systems will perform incorrect unit conversion of liters to milliliters using multiplier 100 instead of 1000, resulting values 10x smaller than actual, which could contribute misdiagnosis or negatively influence patient management

Product Description

ACUSON Maple 1.0 Diagnostic Ultrasound System, REF: 11711750, with software. ACUSON Maple Select 1.0 Diagnostic Ultrasound System, REF: 11711779, with software

Distribution Pattern

US: MS, WA, TX, NJ, GA, PN, NY, AL, MN, NE, IN, CT, CA, IL, TN, WI, ND, NM, AR, NC, PR, RI, WY, MD, FL, HI, AZ, SC, MO, OK, VA, ME, KS, MI, LA, IA, OH, SD, NH, KY, AL, OR, MA, GU. OUS: Afghanistan, Albania, Algeria, Andorra, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Brunei, Bulgaria, Cameroon, Canada, Chile, China, Colombia, Congo, the Democratic Republic of the, Costa Rica, C¿te dIvoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Eritrea, Ethiopia, Faroe Islands, Fiji, Finland, France, French Guinea, French Polynesia, Georgia, Germany, Greece, Guatemala, Guernsey, Guyana, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Islamic Republic of, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kosovo, Kuwait, Latvia, Lebanon, Libya, Liechtenstein LI B, Lithuania, Luxembourg, Macedonia, Malawi, Malaysia, Malta, Mexico, Moldova, Rep. of, Mongolia, Montenegro, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic Korea, Reunion, Romania, Ruanda, Russian Federation, San Marino, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Swaziland, Sweden, Switzerland, Taiwan, Tajikistan, Tanzania, Thailand, Trinidad,Tobago, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Vietnam, Yemen, Zambia, Zimbabwe

Other Recalls by Siemens Medical Solutions USA, Inc.

• Class II: Risk 12/29/2025
  Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be processed.
• Class II: Risk 12/29/2025
  Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be processed.
• Class II: Risk 12/19/2025
  To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
• Class II: Risk 12/19/2025
  To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
• Class II: Risk 12/19/2025
  To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.

View all recalls by Siemens Medical Solutions USA, Inc. →