The system provides the ability to transmit patient data files for… — Class II medical device recall Z-2760-2016
Terminated recall by Invivo Corporation, reported 2016-09-14, distributed nationwide. Display of SpO2 and Non-Invasive Blood Pressure (NIBP) Measurements May Freeze
| Recall number | Z-2760-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Invivo Corporation, Orlando, FL, United States |
| Recall initiated | 2015-10-19 |
| Classified | 2016-09-08 |
| Reported by FDA | 2016-09-14 |
| Terminated | 2019-10-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, CA, CH, CL, DE, DK, DZ, EC, EE, EG, ES, FR, GB, GR, HR, HU, ID, IE, IL, IN, IR, IS, IT, JO, KR, KY, LB, LK, MA, MX, MY, NL, NO, NP, NZ, OM, PA, PH, PK, PL, QA, RO, SA, SE, SG, TH, TN, TR, TW, VN, ZA |
| Quantity | 2,929 |
| Model numbers | FC2010, FC2020 |
Product
The system provides the ability to transmit patient data files for storage, viewing and analysis at distributed locations via the intranet or Internet, or may function as a stand-alone device.
Reason for recall
Display of SpO2 and Non-Invasive Blood Pressure (NIBP) Measurements May Freeze
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-2760-2016. 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.