Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

CAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS, CS08658-03

FDA Device Recall #Z-0043-2019 — Class II — July 31, 2018

Recall Summary

Recall Number Z-0043-2019
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 192

Product Description

CAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS, CS08658-03

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

PA14170895 PA14170897 PA14170903 PA14170930 PA14170937 PA14170944 PA14170952 PA14170954 PA14170956 PA14170961 PA14170962 PA14170963 PA14170964 PA14170965 PA14170966 PA14170967 PA14170968 PA14170969 PA14170970 PA14170971 PA14170973 PA14170974 PA14170975 PA14170976 PA14170977 PA14170978 PA14170979 PA14170980 PA14170981 PA14170982 PA14170983 PA14170984 PA14170985 PA14170986 PA14170987 PA14170988 PA14170989 PA14170990 PA14170991 PA14170992 PA14170993 PA14170994 PA14170995 PA14170996 PA14170997 PA14170998 PA14170999 PA14171000 PA15171001 PA15171002 PA15171003 PA15171004 PA15171005 PA15171006 PA15171007 PA15171008 PA15171009 PA15171010 PA15171011 PA15171012 PA15171013 PA15171014 PA15171015 PA15171016 PA15171017 PA15171018 PA15171019 PA15171020 PA15171021 PA15171022 PA15171023 PA15171024 PA15171025 PA15171026 PA15171027 PA15171028 PA15171029 PA15171030 PA15171031 PA15171032 PA15171033 PA15171034 PA15171035 PA15171036 PA15171037 PA15171038 PA15171039 PA15171040 PA15171041 PA15171042 PA15171043 PA15171044 PA15171045 PA15171046 PA15171047 PA15171048 PA22172187 PA23172256 PA23172257 PA23172258 PA23172259 PA23172260 PA23172261 PA23172262 PA23172263 PA23172264 PA23172265 PA23172266 PA23172267 PA23172268 PA23172269 PA23172270 PA23172271 PA23172272 PA23172273 PA23172274 PA23172275 PA23172276 PA23172277 PA23172278 PA23172279 PA23172280 PA23172281 PA23172282 PA23172283 PA23172284 PA23172285 PA23172286 PA23172287 PA23172288 PA23172289 PA23172290 PA23172291 PA23172292 PA23172294 PA23172295 PA23172296 PA23172297 PA23172298 PA23172299 PA23172301 PA23172398 PA23172399 PA23172400 PA24172401 PA24172402 PA24172404 PA24172405 PA24172406 PA24172407 PA24172409 PA24172410 PA24172412 PA24172414 PA24172416 PA24172417 PA24172418 PA24172419 PA24172420 PA24172421 PA24172422 PA24172423 PA24172424 PA24172425 PA24172426 PA24172427 PA24172428 PA24172429 PA24172430 PA24172431 PA24172432 PA24172433 PA24172435 PA24172436 PA24172437 PA24172438 PA24172439 PA24172440 PA24172443 PA24172444 PA24172445 PA24172446 PA24172447 PA24172448 PA24172449 PA24172450 PA24172451 PA24172452 PA24172453 PA24172454 PA24172455 PA24172472

Other Recalls from Oridion Medical 1987 Ltd.

Recall # Classification Product Date
Z-1376-2025 Class II Microstream Instructions for Use and Part Numbe... Feb 17, 2025
Z-1378-2025 Class II Microstream Instructions for Use and Part Numbe... Feb 17, 2025
Z-1385-2025 Class II Microstream Instructions for Use and Part Numbe... Feb 17, 2025
Z-1377-2025 Class II Microstream Instructions for Use and Part Numbe... Feb 17, 2025
Z-1379-2025 Class II Microstream Instructions for Use and Part Numbe... Feb 17, 2025

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.

More from Oridion Medical 1987 Ltd. Recalls by Firm Recall Reasons Device Safety Stats