Oridion Medical 1987 Ltd. Har Hotzvim Industrial

Entity profile compiled from public source records

Public Record Profile Registrations: 0 510(k) filings: 0 Recalls: 25

Known Identifiers & Locations

FEI Numbers 3001227743
Owner Operator Numbers N/A
Locations Covered N/A

Registered Establishments (0)

No device registration and listing records found for this entity.

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (25)

Recall # Product Description Initiation Date Status Action
Z-0020-2019 CAPNOSTREAM 20 (US) N, Part Number CS08651 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. 2018-07-31 Terminated View Details
Z-0021-2019 CAPNOSTREAM 20P (US) N, Part Number CS08651-01 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. 2018-07-31 Terminated View Details
Z-0022-2019 CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02 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. 2018-07-31 Terminated View Details
Z-0023-2019 CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03 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. 2018-07-31 Terminated View Details
Z-0024-2019 CAPNOSTREAM 20 (US) N W/PRINTER, Part Number CS08657 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. 2018-07-31 Terminated View Details
Z-0025-2019 CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-02 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. 2018-07-31 Terminated View Details
Z-0026-2019 CAPNOSTREAM 20P (US) N W/PRINTER, Part Number CS08657-01 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. 2018-07-31 Terminated View Details
Z-0027-2019 CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-03 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. 2018-07-31 Terminated View Details
Z-0028-2019 Capnostream20 (US) M, Part Number CS08653 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. 2018-07-31 Terminated View Details
Z-0029-2019 Capnostream20 (US) M W/PRINTER, Part Number CS08659 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. 2018-07-31 Terminated View Details
Z-0030-2019 Capnostream20 (US) M TO MASIMO, Part Number CS08750 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. 2018-07-31 Terminated View Details
Z-0031-2019 Capnostream20 (US) M W/PRINTER TO MASIMO, Part Number CS08751 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. 2018-07-31 Terminated View Details
Z-0032-2019 Capnostream20 (US) N REFURBISHED, Part Number CS78651 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. 2018-07-31 Terminated View Details
Z-0033-2019 Capnostream20 (US)M REFURBISHED, Part Number CS78653 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. 2018-07-31 Terminated View Details
Z-0034-2019 Capnostream20 (US) N W/PRINTER REFURBISHED, Part Number CS78657 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. 2018-07-31 Terminated View Details
Z-0035-2019 Capnostream20 (US) M W/PRINTER REFURBISHED, Part Number CS78659 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. 2018-07-31 Terminated View Details
Z-0036-2019 CAPNOSTREAM 20 (INTL) N, Part Number CS08652 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. 2018-07-31 Terminated View Details
Z-0037-2019 CAPNOSTREAM 20P (INTL) N, Part Number CS08652-01 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. 2018-07-31 Terminated View Details
Z-0038-2019 CAPNOSTREAM 20P (INTL) N - ROHS, Part Number CS08652-02 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. 2018-07-31 Terminated View Details
Z-0039-2019 CAPNOSTREAM 20P (INTL) N - ROHS, Part Number CS08652-03 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. 2018-07-31 Terminated View Details
Z-0040-2019 CAPNOSTREAM 20 (INTL) N W/PRINTER, Part Number CS08658 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. 2018-07-31 Terminated View Details
Z-0041-2019 CAPNOSTREAM 20P (INTL) N W/PRINTER, Part Number CS08658-01 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. 2018-07-31 Terminated View Details
Z-0042-2019 CAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS, CS08658-02 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. 2018-07-31 Terminated View Details
Z-0043-2019 CAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS, CS08658-03 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. 2018-07-31 Terminated View Details
Z-0044-2019 Capnostream20 (INTL) M, CS08654 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. 2018-07-31 Terminated View Details

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