Siemens ACUSON Juniper ultrasound systems software unit conversion error
Siemens is recalling ACUSON Juniper ultrasound systems that may perform incorrect unit conversions when configured with non-default settings, potentially producing measurements 10 times smaller than actual values and risking patient misdiagnosis.
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 FDA Class II recall involves a software configuration error that produces incorrect measurement values in a diagnostic device. While no injuries or illnesses have been reported, the risk of misdiagnosis due to values being 10 times smaller than actual represents a potential for serious patient harm, meeting the criteria for a High severity rating.
Plain-English summary
Siemens Medical Solutions USA is recalling ACUSON Juniper diagnostic ultrasound systems, including models 1.0, 1.5, 2.0, and 2.5 (REF 11335791) and Juniper Select models 2.0 and 2.5 (REF 11653093). The recall encompasses 7,022 units distributed across numerous U.S. states, territories, and countries worldwide.
When an operator changes the ultrasound system from factory default settings to use milliliters per second (ml/sec or mL/sec) or milliliters per minute (ml/min or mL/min) as the measurement unit, the system performs an incorrect unit conversion of liters to milliliters. The system uses a multiplier of 100 instead of the correct 1000, producing measurement values that are 10 times smaller than actual values. This error could contribute to misdiagnosis or negatively influence patient management.
The recalled product
- Product
- ACUSON Juniper 1.0, 1.5, 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11335791, with software. ACUSON Juniper Select 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11653093, with software.
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Hazard
- unit-conversion-error
- software-error
- misdiagnosis-risk
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 (7)
- 11335791
- UDI-DI: 04056869152059: 1.0/VA10G and prior
- 1.5/ VB10H and prior
- 2.0/ VB11C and prior
- 2.5/ VB30D and prior. 11653093
- UDI-DI: 04056869957357: 2.0/ VB11C and prior
- 2.5/ VB30D and prior.
Distribution
Distributed in 42 states:
- AL
- AR
- AZ
- CA
- CT
- FL
- GA
- GU
- HI
- IA
- IL
- IN
- KS
- KY
- LA
- MA
- MD
- ME
- MI
- MN
- MO
- MS
- NC
- ND
- NE
- NH
- NJ
- NM
- NY
- OH
- OK
- OR
- PR
- RI
- SC
- SD
- TN
- TX
- VA
- WA
- WI
- WY
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- High