Siemens Diagnostic Ultrasound Systems Recalled for Incorrect Unit Conversion
Siemens ACUSON Maple ultrasound systems may perform incorrect unit conversion in software, producing values 10 times smaller than actual. This could lead to misdiagnosis or inappropriate patient management.
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: FDA Class II diagnostic device with a software defect that produces measurement errors 10-fold lower than actual values, potentially leading to misdiagnosis. No illnesses or injuries have been reported, placing this as a risk-of-harm product where injury has not yet been documented.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling ACUSON Maple 1.0 and ACUSON Maple Select 1.0 Diagnostic Ultrasound Systems. The FDA classifies this as a Class II recall.
The systems have a software defect that affects unit conversion when the display settings are changed from factory default to either milliliters per second (ml/sec) or milliliters per minute (ml/min). When this occurs, the system incorrectly converts liters to milliliters using a multiplier of 100 instead of the correct multiplier of 1000. This results in displayed values that are 10 times smaller than the actual measured values.
The incorrect measurements could contribute to patient misdiagnosis or negatively influence patient management decisions. A total of 321 units have been distributed across the United States (including Puerto Rico and Guam) and internationally to over 100 countries.
Healthcare facilities and operators who use these systems should verify that their software settings remain at factory defaults for milliliters display, or contact Siemens Medical Solutions USA, Inc. for guidance on proper settings and software updates to correct this issue.
The recalled product
- Product
- ACUSON Maple 1.0 Diagnostic Ultrasound System, REF: 11711750, with software. ACUSON Maple Select 1.0 Diagnostic Ultrasound System, REF: 11711779, with software
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Affected units
- 321
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 (5)
- 11711750
- UDI-DI: 04056869995809
- Software VA10A 11711779
- UDI-DI: 04056869995830
- Software VA10A
Distribution
Part of a larger recall action
This product is one of 3 recalled by Siemens Medical Solutions USA, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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