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.
What this means for you
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, Gyneolo
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Hazard
- software-malfunction
- data-loss
- treatment-delay
Distribution
Distributed nationwide across the United States.
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