Recall Z-2276-2019— NeuroLogica Corporation
Class II · Terminated
Class II FDA medical device recall by NeuroLogica Corporation, initiated 2019-07-25, terminated 2020-09-11. It names 2 FDA 510(k) clearances: K173513, K153529. 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, 4.01.08, 4.01.09.. Reason: 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..
- Recalling firm
- NeuroLogica Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-07-25
- Terminated
- 2020-09-11
- Firm location
- Danvers, MA, United States
510(k) clearances named in this recall
2 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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, 4.01.08, 4.01.09.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.