Diagnostic Ultrasound System — Class II medical device recall Z-0748-2022
Ongoing recall by Siemens Medical Solutions USA, Inc., reported 2022-03-23, distributed nationwide. The clip store function in the ultrasound imaging system does not work when the system has a disk full error.
| Recall number | Z-0748-2022 |
|---|---|
| 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 | 2022-01-19 |
| Classified | 2022-03-11 |
| Reported by FDA | 2022-03-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BR, CA, CH, CL, CN, CO, CR, CZ, DE, DK, DZ, EC, EG, ES, FR, GB, GR, HK, HR, HU, ID, IE, IL, IN, IT, JP, KR, KW, LT, LU, LV, MA, MX, MY, NL, NO, NZ, OM, PE, PH, PL, PT, QA, RO, RS, SA, SE, SG, SI, SK, SV, TH, TR, TW, UA, UY, VN, ZA |
| Quantity | 2,846 |
| UPC / GTIN / UDI-DI | 04056869152059 |
| Serial numbers | 550010, 550011, 550015, 550016, 550018, 550019, 550020, 550021, 550023, 550024, 550025, 550026, 550027, 550028, 550029, 550030, 550031, 550032, 550033, 550034, 550035, 550036, 550037, 550038, 550039 and 475 more |
| Model numbers | 11335791 |
Product
Diagnostic Ultrasound System, ACUSON Juniper, UDI: (01)04056869152059, Model: 11335791, Rx, CE Ultrasound imaging system intended for the following applications: Vascular, Abdominal, Neonatal, Echocardiographical, Pediatric, Small Parts, Musculoskeletal, Obstetrical, Gyneological, Intraoperative, and Urological applications using different ultrasound transducers for different applications.
Reason for recall
The clip store function in the ultrasound imaging system does not work when the system has a disk full error. This could cause a delay in treatment if the ultrasound system is unable to save clips as study documentation during a high risk procedure, such as a stress echo exam.
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-0748-2022. 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.