CARESCAPE Respiratory Module E-sCAiOV
FDA Device Recall #Z-0757-2020 — Class I — September 27, 2019
Recall Summary
| Recall Number | Z-0757-2020 |
| Classification | Class I — Serious risk |
| Date Initiated | September 27, 2019 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | GE Healthcare, LLC |
| Location | Waukesha, WI |
| Product Type | Devices |
| Quantity | 37 units |
Product Description
CARESCAPE Respiratory Module E-sCAiOV
Reason for Recall
Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could cause up to 50% measurement error in the EtO2/FiO2 values.
Distribution Pattern
US OUS: Australia, Austria, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Finland, France, Germany, Hong Kong, India, Indonesia, Ireland, Italy, Japan, Korea (Republic of), Malaysia, Mexico, Myanmar, Netherlands, New Zealand, Peru, Poland, Republic of Serbia, Romania, Russia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Uganda, and Unites Kingdom
Lot / Code Information
Mfg. Lot or Serial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ot Applicable
Other Recalls from GE Healthcare, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1566-2022 | Class II | (1) GE Centricity Universal Viewer 6.0, Model 2... | Jul 15, 2022 |
| Z-1430-2022 | Class II | SIGNA Premier magnetic resonance scanner, model... | Jun 24, 2022 |
| Z-1466-2022 | Class II | Centricity PACS Software Version 7.0 SP0.0.4.7 | Jun 14, 2022 |
| Z-1333-2022 | Class II | GE Centricity Universal Viewer Zero Footprint. ... | Jun 8, 2022 |
| Z-1511-2022 | Class II | Service manuals for the CT, PET, or NM table as... | Jun 2, 2022 |
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.