NeuroLogica HS70A Ultrasound Systems Recalled for Probe Overheating Risk
NeuroLogica is recalling HS70A Diagnostic Ultrasound Systems due to a potential risk of probes overheating 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 the hazard involves a risk of harm (overheating) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
NeuroLogica Corporation is recalling HS70A Diagnostic Ultrasound Systems, including specific software versions 2.01.00 through 2.01.06 and 1.00.06 through 1.00.12. The recall involves 3,582 units distributed nationwide in the United States.
The recall is issued 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 should stop using the affected systems and contact NeuroLogica Corporation for instructions on how to resolve the issue. The FDA has classified this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- HS70A Diagnostic Ultrasound System Version 2.01.00, 2.01.01, 2.01.02, 2.01.03, 2.01.04, 2.01.05, 2.01.06, 1.00.06, 1.00.07, 1.00.08, 1.00.09, 1.00.10, 1.00.11, 1.00.12
- Manufacturer
- NeuroLogica Corporation
- Hazard
- Affected units
- 3,582
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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