Oridion Medical 1987 Ltd.: Capnostream20 (INTL) M, CS08654

Recall number

Z-0044-2019

Recalling firm

Oridion Medical 1987 Ltd.

Product

Capnostream20 (INTL) M, CS08654

Status

Terminated

Initiated

2018-07-31

Posted

not on file

Terminated

2022-09-20

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.

Root cause

Nonconforming Material/Component

Action

Urgent Medical Device Correction notification letters dated 7/31/18 were distributed to customers. The letters included the following instructions for customers: Share this notification with all care environments where the Capnostream" 20 and Capnostream" 20p bedside patient monitors are used, particularly in the areas where nurse call may be enabled (general care floors). If your facility has distributed these bedside patient monitors to other persons or facilities, please promptly forward a copy of this letter to those recipients. Medtronic is recommending continued use of Capnostream" devices. Users should confirm that the date/time is accurately displayed. If the date/time requires reset, all user defined settings, such as alarms and nurse call, will also require reset until the software is updated. Please follow the instruction in the Operators Manual to set user-defined default settings. The Operators Manual is available at http://www.medtronic.com/covidien/enus/support/product-manuals.html, refer to the Institutional Settings section. Return the completed Acknowledgement and Receipt Form by fax or email even if you have no inventory. In October 2018, download the software update from the Medtronic website via the following link which includes directions on how to download and install the software: http://www.medtronic.com/covidien/en-us/support/patient-monitoring-equipmentsoftware-upgrades.html.

Quantity

56

Distribution

The products were distributed US nationwide and Puerto Rico. The products were distributed to the following foreign countries: Argentina, Australia, Austria, Bahrain, Belgium, Canada, Columbia, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Kazakhstan, Kuwait, Mexico, Netherlands, Norway, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, UAE, UK, and Vietnam.

Lot, serial or model codes

B300001030 B300001023 B300001019 B300001021 B300001022 B300001027 B300001037 B300001038 B300001039 B300001020 B300001034 B300001076 B300001449 B300001418 B300001430 B300001458 B300001466 B300001469 B500001545 B500001546 B500001552 B500001558 B500001578 B500001579 B500001591 B30001370 B300001310 B500001551 B500001589 B500001770 B500001761 B500001765 B500001962 B500001982 B500001949 B500001921 B500001922 B500001923 B500001940 B500001947 B500001972 B500001975 B500001993 B500001989 B500002043 B500002767 B500001820 B500002596 B500002601 B500002605 B500002606 B500002607 B500002735 B500002740 B500002743 B500002759

510(k) numbers

not on file

PMA numbers

not on file

Product code

DQA

Firm FEI

3001227743

Firm city

Jerusalem

Firm state

Har Hotzvim Industrial Park

Firm country

Israel

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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