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CAPNOSTREAM 20P (INTL) N, Part Number CS08652-01

FDA Device Recall #Z-0037-2019 — Class II — July 31, 2018

Recall Summary

Recall Number Z-0037-2019
Classification Class II — Moderate risk
Date Initiated July 31, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Oridion Medical 1987 Ltd.
Location Jerusalem
Product Type Devices
Quantity 113

Product Description

CAPNOSTREAM 20P (INTL) N, Part Number CS08652-01

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.

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.

Lot / Code Information

B642138114 B642138116 B642138122 B643138126 B643138128 B643138132 B643138134 B643138139 B643138144 B643138146 B643138150 B643138153 B643138156 B643138160 B643138166 B643138167 B643138168 B643138169 B643138170 B643138171 B643138172 B643138175 B643138177 B643138179 B643138181 B643138182 B643138190 B643138192 B643138215 B643138216 B643138217 B643138218 B643138219 B643138222 B643138224 B643138225 B643138228 B643138230 B643138232 B643138233 B643138240 B643138241 B643138243 B643138245 B643138253 B644138256 B644138259 B644138286 B644138287 B644138291 B610148829 B610148834 B610148838 B610148845 B611148924 B611148945 B611148946 B611148951 B612149038 B612149039 B615149045 B615149050 B615149054 B615149060 B615149062 B615149063 B615149070 B615149071 B615149073 B615149074 B615149086 B615149088 B615149090 B621149514 B622149593 B622149651 B622149654 B622149655 B622149658 B622149660 B622149663 B622149664 B622149665 B622149666 B622149668 B622149669 B622149670 B622149673 B622149674 B622149675 B622149680 B622149696 B622149701 B622149683 B622149685 B622149695 B622149697 B623149711 B623149712 B623149715 B623149716 B623149719 B624149862 B624149863 B624149866 B624149867 B624149876 B624149877 B624149880 B624149883 B624149887 B624149900 B643138174

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Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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