The Recall Desk
HighFDA (Devices)·Z-2471-2021·Announced 2021-09-22

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.

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 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.
Hazard
  • power-supply-failure
  • device-inoperability

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

Distributed nationwide across the United States.