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CAPNOSTREAM 20P (INTL) N W/PRINTER, Part Number CS08658-01

FDA Device Recall #Z-0041-2019 — Class II — July 31, 2018

Recall Summary

Recall Number Z-0041-2019
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 W/PRINTER, Part Number CS08658-01

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

B638137550 B638137552 B638137553 B638137554 B638137556 B638137559 B638137562 B638137567 B638137568 B638137569 B638137572 B638137573 B638137574 B638137575 B638137576 B638137578 B638137581 B638137584 B638137587 B638137589 B638137594 B638137597 B638137598 B642138045 B642138050 B642138053 B642138054 B642138057 B642138061 B642138064 B642138073 B642138076 B642138077 B642138079 B642138080 B642138081 B642138085 B642138094 B642138097 B642138099 B642138107 B642138108 B642138109 B638137571 B616149193 B616149199 B616149200 B616149204 B616149209 B616149213 B616149216 B616149217 B616149218 B616149233 B625140084 B625140085 B625140087 B625140088 B625140089 B625140090 B625140092 B625140093 B625140094 B625140096 B625140098 B625140101 B625149944 B625149945 B625149946 B625149947 B625149948 B625149950 B625149951 B625149952 B625149953 B625149955 B625149956 B625149957 B625149958 B625149959 B625149960 B625149961 B625149962 B625149963 B625149964 B625149965 B625149966 B625149967 B625149970 B625149971 B625149972 B625149973 B625149974 B625149975 B625149977 B625149978 B625149979 B625149981 B625149982 B625149983 B625149984 B625149985 B625149986 B625149988 B625149989 B625149990 B625149991 B625149992 B625149994 B625149996 B625149997 B625149999 B625149976

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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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