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
Reported: August 21, 2019 Initiated: July 25, 2019 #Z-2275-2019
Product Description
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
Reason for Recall
There is a potential for probes overheating when decreasing the Doppler SV (Sample Volume) size value set by the user in the Doppler Only mode.
Details
- Recalling Firm
- NeuroLogica Corporation
- Units Affected
- 3582 worldwide
- Distribution
- US Nationwide
- Location
- Danvers, MA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by NeuroLogica Corporation. Units affected: 3582 worldwide.
Why was this product recalled? ▼
There is a potential for probes overheating when decreasing the Doppler SV (Sample Volume) size value set by the user in the Doppler Only mode.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 21, 2019. Severity: Moderate. Recall number: Z-2275-2019.
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