NeuroLogica WS80A Diagnostic Ultrasound System Recalled for Probe Overheating Risk
NeuroLogica is recalling WS80A Diagnostic Ultrasound Systems because probes may overheat when users decrease the Doppler Sample Volume size in Doppler Only mode.
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: The recall is classified as FDA Class II and involves a risk of harm (probe overheating) where specific injury reports are not detailed in the source text, fitting the criteria for a high-risk product where injury has not yet been reported.
Plain-English summary
NeuroLogica Corporation is recalling 5,088 WS80A Diagnostic Ultrasound Systems worldwide. The recall covers specific software versions, including 1.00.16, 3.00.17 through 3.01.09, and 4.00.08 through 4.01.09. The devices were distributed nationwide in the United States.
The recall was initiated because there is a potential for the ultrasound probes to overheat. This risk occurs specifically when a user decreases the Doppler Sample Volume (SV) size value while the system is set to Doppler Only mode.
Healthcare facilities and users of these systems should stop using the affected devices and contact NeuroLogica Corporation for instructions on corrective actions. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- WS80A Diagnostic Ultrasound System Version 1.00.16, 3.00.17, 3.00.18, 3.00.19, 3.01.00, 3.01.01, 3.01.02, 3.01.03, 3.01.04, 3.01.05, 3.01.06, 3.01.07, 3.01.08, 3.01.09, 4.00.08, 4.00.09, 4.00.10, 4.00.11, 4.01.00, 4.01.01, 4.01.02, 4.01.03, 4.01.04, 4.01.05, 4.01.06, 4.01.07, 4
- Manufacturer
- NeuroLogica Corporation
- Hazard
- Affected units
- 5,088
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by NeuroLogica Corporation 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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