CAPNOSTREAM 20 — Class II medical device recall Z-0036-2019
Terminated recall by Oridion Medical 1987 Ltd., reported 2018-10-10, distributed nationwide. The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default
| Recall number | Z-0036-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Oridion Medical 1987 Ltd., Jerusalem, Israel |
| Recall initiated | 2018-07-31 |
| Classified | 2018-10-03 |
| Reported by FDA | 2018-10-10 |
| Terminated | 2022-09-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BH, CA, CH, CR, CZ, DE, DK, ES, FI, FR, GB, GR, HR, HU, IE, IL, IT, JP, KW, MX, NL, NO, OM, PA, PE, PH, PK, PL, PT, QA, RO, RS, RU, SA, SE, SG, SI, SK, TH, TN, TR, VN, ZA |
| Quantity | 245 |
| Model numbers | CS08652 |
Product
CAPNOSTREAM 20 (INTL) N, Part Number CS08652
Reason for recall
The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
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-0036-2019. 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.