HS70A Diagnostic Ultrasound System Version 2 — Class II medical device recall Z-2275-2019
Terminated recall by NeuroLogica Corporation, reported 2019-08-21, distributed nationwide. There is a potential for probes overheating when decreasing the Doppler SV (Sample Volume) size value set by t
| Recall number | Z-2275-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | NeuroLogica Corporation, Danvers, MA, United States |
| Recall initiated | 2019-07-25 |
| Classified | 2019-08-14 |
| Reported by FDA | 2019-08-21 |
| Terminated | 2020-09-11 |
| Distributed | Nationwide (US) |
| Quantity | 3,582 worldwide |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 08806167789220 |
| Serial numbers | S15NM3HK100001X, S15NM3HK200005N, S1C0M3HK300001K, S1C0M3HK300002Z, S1C0M3HK300004A, S1C0M3HK300005P, S1C0M3HK300006D, S1C0M3HK300007X, S1C0M3HK300008N, S1C0M3HK400001L, S1C0M3HK400002T, S1C0M3HK400003B, S1C0M3HK400005Z, S1C0M3HK400006Y, S1C0M3HK400008P, S1C0M3HK700001N, S1C0M3HK700002E, S1C0M3HK800001P, S1C0M3HK800002D, S1C0M3HK900001Z, S1C0M3HK900002Y, S1C0M3HK900003A, S1C0M3HK900004P, S1C0M3HK900005D, S1C0M3HK900006X and 7 more |
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2275-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.