FDA Device Recall Z-0035-2019: Oridion Medical 1987 Ltd. Har Hotzvim Industrial

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0035-2019.

Recall Res Number

Z-0035-2019

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 W/PRINTER REFURBISHED, Part Number CS78659

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 B200001278 B300001166 B300001220 B300001070 B300001092 B300001097 B300001108 B300001172 B300001181 B300001185 B300001205 B300001278 B300001115 B500001885 B500001831 B300001015 B300001118 B500002336 B300001012 B300001132 B300001139 B500001819

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FUKUDA DENSHI CO., LTD. Registration: 9611031 View Registration
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RADIOMETER BASEL AG Registration: 9614470 View Registration
S.L.P. LTD. Registration: 9614500 View Registration
HAMAMATSU PHOTONICS K.K., SYSTEMS DIVISION Registration: 9614683 View Registration
MIR - MEDICAL INTERNATIONAL RESEARCH S.P.A. Registration: 9614860 View Registration
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-0035-2019

Recall Parameters & Description

Related Establishments / Registrations

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