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

FDA Device Recall #Z-0040-2019 — Class II — July 31, 2018

Recall Summary

Recall Number Z-0040-2019
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 144

Product Description

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

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

B200001028 B200001034 B200001060 B200001022 B200001023 B200001038 B200001041 B200001042 B200001052 B200001054 B200001055 B200001056 B200001024 B200001039 B200001040 B200001049 B200001051 B200001058 B200001059 B200001026 B200001029 B200001037 B200001031 B200001094 B200001033 B200001172 B200001228 B200001050 B200001459 B200001025 B400002243 B200001045 B200001047 B200001044 B200001138 B200001689 B200001832 B200001837 B200001854 B200001855 B200001645 B200001633 B200001917 B400002296 B400002401 B400002435 B400002444 B400002350 B400002453 B400002451 B400002454 B200001839 B200001573 B440112951 B440112966 B440112973 B417123382 B417123383 B417123387 B440112949 B417123381 B417123384 B417123386 B417123385 B410123238 B447123766 B447123768 B447123769 B448123792 B200002165 B411134508 B411134523 B411134459 B411134469 B440112945 B400002441 B416135016 B416135070 B400002237 B423135806 B423135807 B423135808 B423135811 B424135818 B424135821 B424135824 B424135828 B424135830 B424135832 B424135833 B424135835 B424135836 B424135839 B424135842 B424135843 B424135846 B424135848 B424135853 B424135856 B424135859 B424135861 B200001159 B428136417 B428136419 B428136423 B428136425 B428136427 B428136428 B428136431 B428136432 B428136438 B428136444 B428136445 B428136447 B428136455 B428136459 B428136462 B428136464 B428136466 B428136407 B428136408 B428136414 B428136418 B428136421 B428136422 B428136424 B428136426 B428136429 B428136434 B428136436 B428136441 B428136443 B428136446 B428136449 B428136450 B428136452 B428136456 B428136457 B428136458 B428136461 B428136463 B200001053 B407123203 B428136416

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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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