FDA Device Recall Z-0030-2019: Oridion Medical 1987 Ltd. Har Hotzvim Industrial

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0030-2019.

Recall Res Number

Z-0030-2019

Recalling Firm / Manufacturer

Oridion Medical 1987 Ltd. Har Hotzvim Industrial

FEI Number

3001227743

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2018-07-31

Date Posted

N/A

Date Terminated

2022-09-20

Product Code

DQA

Event Number

80895

Product Quantity

Product Description Capnostream20 (US) M TO MASIMO, Part Number CS08750

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.

Action Details 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.

Distribution Pattern 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.

Code Information / Serial Numbers B500002658

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Jaeger Medical GmbH Registration: 9615102 View Registration
EB NEURO, S.P.A. Registration: 9617286 View Registration
AVITA CORPORATION Registration: 9617543 View Registration
BREAS MEDICAL AB Registration: 9617566 View Registration
VELCROMEX, S.A. DE C.V. Registration: 9680215 View Registration
Nicolay GMBH Registration: 9681377 View Registration
GE MEDICAL SYSTEMS (CHINA) CO., LTD. Registration: 9710602 View Registration

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This page represents an index of public-record FDA device recalls. It does not imply current safety or compliance status of the product. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Refer to official government sources for primary safety alerts.

Medical Device Recall: Z-0030-2019

Recall Parameters & Description

Related Establishments / Registrations

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