Product Label — Class II medical device recall Z-1330-2021
Ongoing recall by Siemens Medical Solutions USA, Inc., reported 2021-04-07, distributed in AK, AL, AR, AZ, CA, CT, DE, FL…. The ultrasound system averages the Mean Sac Diameter (MSD) and Gestational Sac Diameter (GSD) into the Estimat
| Recall number | Z-1330-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc., Issaquah, WA, United States |
| Recall initiated | 2021-02-04 |
| Classified | 2021-04-01 |
| Reported by FDA | 2021-04-07 |
| Distributed | AK, AL, AR, AZ, CA, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY |
| Countries outside the US | AE, AT, AU, BE, BR, CA, CH, CL, CN, CO, CR, CZ, DE, DK, DZ, ES, FI, FR, GB, GR, HK, HR, ID, IL, IN, IR, IT, JP, KR, KW, MA, MX, NL, NZ, OM, PH, PL, PT, QA, RO, SA, SE, SG, SI, SK, TH, TR, TW, UA, VN, ZA |
| Quantity | 1,172 systems |
| Serial numbers | 800015, 800101, 800103, 800104, 800105, 800106, 800107, 800108, 800109, 800111, 800112, 800113, 800114, 800115, 800116, 800117, 800118, 800119, 800120, 800121, 800122, 800123, 800126, 800127, 800129 and 475 more |
| Model numbers | 11148775 |
Product
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
Reason for recall
The ultrasound system averages the Mean Sac Diameter (MSD) and Gestational Sac Diameter (GSD) into the Estimated Date of Delivery (EDD) calculation. This may result in an incorrect EDD, which may influence patient management decisions regarding induction of labor and elective caesarean delivery, which may result in premature births.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1330-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.