Siemens ACUSON Juniper ultrasound system recalled for intermittent power supply failure
Siemens Medical Solutions USA is recalling 15 ACUSON Juniper Diagnostic Ultrasound Systems worldwide due to intermittent power supply failures that render the devices inoperable. No injuries or illnesses have been reported.
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 a Class II device recall for a risk-of-harm product where injury has not yet been reported. The intermittent power supply failure renders the diagnostic ultrasound system inoperable, potentially disrupting patient care workflows, but no injuries or illnesses have been documented in the source text.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling the ACUSON Juniper Diagnostic Ultrasound System (Model 11335791). The recall affects 15 systems distributed worldwide, including throughout the United States, Puerto Rico, and internationally to Bosnia Herzegovina, Canada, Colombia, Germany, Greece, Italy, North Macedonia, Poland, and Slovenia.
The devices are being recalled due to intermittent failures of the power supply that render the ultrasound systems inoperable. When these failures occur, the devices cannot operate and cannot be used for patient care.
Healthcare facilities and providers who have received affected systems should contact Siemens Medical Solutions USA, Inc. for corrective action instructions. The FDA classifies this as a Class II device recall. No injuries or illnesses have been reported to date.
The recalled product
- Product
- ACUSON Juniper Diagnostic Ultrasound System
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Affected units
- 15
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (16)
- O.U.S. Serial Numbers: 550975
- 552770
- 553629
- 553951
- 555060
- 555601
- 555602
- 555604
- 555605
- 555610
- 555611
- 555612
- 555613
- 555626
- O.U.S. Inactive Serial Numbers: 555603
- 555607
Distribution
Related recalls
Same manufacturer · Siemens Medical Solutions USA, Inc.
See all →- ModerateARTIS icono biplane medical imaging system detector lift malfunction
FDA (Devices) · 2026-07-08
- HighARTIS icono floor Medical Imaging System Detector Movement Loss Recall
FDA (Devices) · 2026-07-08
- ModerateARTIS icono ceiling medical imaging monitor suspension system
FDA (Devices) · 2026-07-08
- HighARTIS Icono Ceiling Model 11328100 Loss of Movement Capability Recall
FDA (Devices) · 2026-07-08
- HighARTIS pheno systems may display zero dose while dose is applied
FDA (Devices) · 2026-06-10
Same hazard · power supply failure
See all →- HighGalaxy System bronchoscope power supply defect may injure lung tissue
FDA (Devices) · 2025-01-01
- HighBD FACSLyric Flow Cytometer Power Supply May Fail During Use
FDA (Devices) · 2025-01-01
- HighMedical Device Recall: BD FACSLyric Flow Cytometer Power Supply Failure Risk
FDA (Devices) · 2025-01-01
- HighPhilips Patient Information Center iX UPS devices recalled for potential power failure
FDA (Devices) · 2024-05-01
- ModeratePrucka 3 Amplifier Power Supply May Fail and Cause Device Inoperability
FDA (Devices) · 2023-09-27
Similar recalls
- HighSiemens ACUSON Juniper ultrasound systems software unit conversion error
FDA (Devices) · 2024-10-02
- HighDiagnostic ultrasound system ACUSON Juniper fails to save study clips
FDA (Devices) · 2022-03-23
- ModerateSiemens ACUSON S Family Ultrasound Systems Recalled for Measurement Error
FDA (Devices) · 2014-07-09
- HighSiemens ACUSON NX3 Ultrasound Systems Recalled for Acoustic Output Power Defect
FDA (Devices) · 2019-08-28
- HighSiemens ACUSON SC2000 Ultrasound System Recalled for Loose User Interface
FDA (Devices) · 2014-02-05
- ModerateSiemens ACUSON SC2000 Ultrasound System Recalled for Control Panel Lock Failure
FDA (Devices) · 2014-02-05