Open, Classified

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

FDA Recall Z-3217-2024 · Posted 2024-09-24

Recalling FirmSiemens Medical Solutions USA, Inc.

Recall StatusOpen, Classified

Product CodeIYN

Date Initiated2024-08-15

Product Quantity321

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

Firm Action

On 8/15/2024, correction notices were distributed to customers who were asked to do the following: To avoid potential misdiagnosis by an under-represented volume flow measurement value, use the factory default display configuration of l/min (liters per minute). Review of previous examination results ONLY if a clinical assessment reviewed a volume flow measurement(s) with the unit of measurement configured to display a value in milliliters. Firm's Customer Service Engineer will contact you to schedule a facility visit to update the system or inform you of a remote update when the software update is available. The software update is currently under development and estimated to be available in the summer of 2024. Ensure that all users of ACUSON Juniper and ACUSON Maple systems within your organization, and others who may need to be informed, receive the safety relevant information provided with this notice and take the actions specified herein. If you have further questions, please contact the firm's Ultrasound Service Customer Care Center at 1-800-888-7436.

Root Cause

Software design

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K232617ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2023-09-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.