# FDA recall Z-0748-2022

> **Siemens Medical Solutions USA, Inc.** · Class II · device recall initiated 2022-01-19.

## 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.

## Distribution

Worldwide distribution: US (nationwide) and countries of:  Algeria, Andorra, Argentina, Australia, Austria, Bangladesh, Belgium, Bosnia Herzeg, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Faroe Islands, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Kosovo, Kuwait, Latvia, Liechtenstein, Lithuania, Luxembourg, Malaysia, Mexico, Morocco, Myanmar, Namibia, Netherlands, New Zealand, Norway, Oman, Peru, Philippines, Poland, Portugal, Qatar, Rep. of Yemen, Republic Korea, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sudan, Sweden, Switzerland, Taiwan, Thailand, Turkey, U.A.E., Ukraine, United Kingdom, Uruguay, Vietnam, and Zimbabwe.

## Key facts

- **Recall number:** Z-0748-2022
- **Recalling firm:** Siemens Medical Solutions USA, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-01-19
- **Report date:** 2022-03-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Issaquah, WA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0748-2022

## Citation

> AI Analytics. FDA recall Z-0748-2022. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-0748-2022. Source: US FDA. Licensed CC0.

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