Agency classClass IIOur severity:High FDA (Devices)·Z-0748-2022·Announced 2022-03-23

Diagnostic ultrasound system ACUSON Juniper fails to save study clips

The ACUSON Juniper ultrasound system's clip storage function fails when the disk is full, potentially delaying treatment during critical imaging procedures. Healthcare facilities using this system should contact Siemens for support.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is a software malfunction affecting documentation capability that could delay treatment during critical procedures, representing a theoretical risk of harm rather than actual patient injury.

Plain-English summary

Siemens is recalling the ACUSON Juniper diagnostic ultrasound system due to a malfunction in the clip storage function. When the system's storage disk becomes full, the system cannot save video clips from imaging studies, which serve as critical documentation for patient care.

This issue could delay treatment, particularly during time-sensitive procedures such as stress echo examinations, where documented imaging is essential for clinical decision-making. The recall affects 2,846 units distributed worldwide across the United States and numerous international markets.

Healthcare facilities operating the ACUSON Juniper system should ensure adequate disk storage space is maintained and contact Siemens Medical Solutions USA, Inc. for firmware updates or other remediation measures if this issue is encountered.

The recalled product

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…
Manufacturer: Siemens Medical Solutions USA, Inc.
Category: Medical Device — Diagnostic Ultrasound
Hazard: software-malfunction
data-loss
treatment-delay
Affected units: 2,846

Distribution

Distributed nationwide across the United States.

Same manufacturer · Siemens Medical Solutions USA, Inc.

See all →

Moderate
ARTIS icono biplane medical imaging system detector lift malfunction
FDA (Devices) · 2026-07-08
High
ARTIS icono floor Medical Imaging System Detector Movement Loss Recall
FDA (Devices) · 2026-07-08
Moderate
ARTIS icono ceiling medical imaging monitor suspension system
FDA (Devices) · 2026-07-08
High
ARTIS Icono Ceiling Model 11328100 Loss of Movement Capability Recall
FDA (Devices) · 2026-07-08
High
ARTIS pheno systems may display zero dose while dose is applied
FDA (Devices) · 2026-06-10

Same hazard · software malfunction