ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B — Class II medical device recall Z-0547-2022
Ongoing recall by Siemens Medical Solutions USA, Inc., reported 2022-02-09, distributed nationwide. Due to a calculation error in the measurement when using 2D trace (manual trace) tool. The trace circumference
| Recall number | Z-0547-2022 |
|---|---|
| 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 | 2021-11-12 |
| Classified | 2022-02-01 |
| Reported by FDA | 2022-02-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BD, BE, BH, BR, CH, CL, CN, CO, CY, CZ, DE, DK, EG, ES, FI, FR, GB, GR, GT, HK, HR, ID, IL, IS, IT, JP, KR, KW, LT, LU, MX, NL, NZ, PL, PT, QA, RO, RS, SA, SE, SG, SK, TH, TR, TW, UA, ZA |
| Quantity | 1,161 systems |
| Serial numbers | 800101, 800106, 800117, 800126, 800135, 800136, 800138, 800140, 800142, 800147, 800157, 800159, 800162, 800163, 800171, 800176, 800177, 800181, 800182, 800183, 800184, 800185, 800186, 800187, 800190 and 475 more |
Product
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
Reason for recall
Due to a calculation error in the measurement when using 2D trace (manual trace) tool. The trace circumference value is overestimated and may potentially result in misdiagnosis of a patient's condition.
Machine access
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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.