Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0040-2019 — CAPNOSTREAM 20 (INTL) N W/PRINTER, Part Number CS08658

U.S. FDA — Device Enforcement · Israel · 2018-07-31 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0040-2019
Date of alert
2018-07-31
Country / jurisdiction
Israel
Risk level
Class II
Risk type
recall
Brand
Oridion Medical 1987 Ltd.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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