Oridion Medical 1987 Ltd.: CAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS, CS051COV-03

Recall number

Z-0056-2019

Recalling firm

Oridion Medical 1987 Ltd.

Product

CAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS, CS051COV-03

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

PM31170001 PM31170002 PM31170003 PM31170004 PM31170005 PM31170006 PM31170007 PM31170008 PM37170009 PM37170010 PM37170011 PM37170012 PM37170013 PM37170014 PM37170015 PM37170016 PM37170017 PM37170018 PM37170019 PM37170020 PM37170021 PM37170022 PM37170023 PM37170024 PM37170025 PM37170026 PM37170027 PM37170028 PM37170029 PM37170030 PM37170031 PM37170032 PM37170033 PM37170034 PM37170035 PM37170036 PM37170037 PM37170038 PM37170039 PM37170040 PM37170041 PM37170042 PM37170043 PM37170044 PM37170045 PM37170046 PM37170047 PM37170048 PM37170049 PM37170050 PM37170051 PM37170052 PM37170053 PM37170054 PM37170055 PM37170056

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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