Agency classClass IIOur severity:High FDA (Devices)·Z-2276-2019·Announced 2019-08-21

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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…
Manufacturer: NeuroLogica Corporation
Category: Medical Device — Diagnostic Ultrasound
Hazard: overheating
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.

See all 2 products in this recall →

Same manufacturer · NeuroLogica Corporation

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Same hazard · overheating