Recall Z-0052-2019— Oridion Medical 1987 Ltd.
Class II · Terminated
Class II FDA medical device recall by Oridion Medical 1987 Ltd., initiated 2018-07-31, terminated 2022-09-20. FDA's recall record names no specific 510(k) clearance for this event. Product: Capnostream20 (INTL) M REFURBISHED, CS78654. Reason: 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..
- Recalling firm
- Oridion Medical 1987 Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-07-31
- Terminated
- 2022-09-20
- Firm location
- Jerusalem, Israel
Product description
Capnostream20 (INTL) M REFURBISHED, CS78654
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.