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GE Healthcare, Avance, Avance CS2, Amingo.

FDA Device Recall #Z-0755-2017 — Class II — November 3, 2016

Recall Summary

Recall Number Z-0755-2017
Classification Class II — Moderate risk
Date Initiated November 3, 2016
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm GE Healthcare, LLC
Location Waukesha, WI
Product Type Devices
Quantity 23,098 (US = 8,711; OUS = 14,387)

Product Description

GE Healthcare, Avance, Avance CS2, Amingo.

Reason for Recall

GE Healthcare has become aware of a potential safety issue where certain Avance CS2, Avance and Amingo anesthesia devices can transition to a System Malfunction state if the lower storage drawer containing the optional large tray insert accessory closed with an abnormally high amount of force.

Distribution Pattern

USA ( nationwide) Distribution including Puerto Rico and DC. and to the countries of Australia AUSTRIA Azerbaijan Bahrain Bangladesh Barbados Belarus Belgium BOLIVIA BOSNIA-HERZEGOVINA Brazil BRUNEI BULGARIA Canada CHILE China COLOMBIA COSTA RICA Croatia Cyprus Czech Republic Denmark ECUADOR Egypt Estonia Ethiopia Finland FRANCE Georgia GERMANY Ghana Gibraltar GREECE HONG KONG HUNGARIA Iceland India Indonesia IRAQ Ireland Israel ITALY JAPAN JORDAN KAZAKHSTAN Kenya KOREA, REPUBLIC OF Kuwait Latvia Lebanon Libyan Arab Jamahiriya LITHUANIA MACEDONIA MALAYSIA Malta Mexico MOLDOVA MOROCCO NAMIBIA Netherlands New Zealand Nicaragua Nigeria NORWAY Oman Pakistan Panama PARAGUAY PERU PHILIPPINES Poland PORTUGAL Qatar ROMANIA Russian Federation Saudi Arabia Serbia SERBIA-MONTENE Singapore Slovakia SLOVENIA SOUTH AFRICA SPAIN SWEDEN SWITZERLAND SYRIA TAIWAN Thailand Tunisia TURKEY Ukraine United Arab Emirates UNITED KINGDOM Uruguay UZBEKISTAN Venezuela VietNam Yemen

Lot / Code Information

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ANBJ00553 ANBJ00554 ANBJ00555 ANBJ00557 ANBK00482 ANBK00483 ANBK00484 ANBK00485 ANBK00486 ANBK00487 ANBK00488 ANBK00489 ANBK00490 ANBK00491 ANBK00492 ANBK00493 ANBK00494 ANBJ00558 ANBM00943 ANBK00425 ANBK00426 ANBK00427 ANBK00428 ANBK00429 APKT00842 APKT00843 APKU01689 APKU01690 APKU01691 APKU01692 APKU01693 ANBK00389 ANBK00390 ANBK00391 ANBK00392 ANBK00393 ANBK00394 ANBK00395 ANBK00396 ANBK00397 ANBK00398 ANBK00430 ANBM01914 ANBN01657 ANBN01658 ANBN01660 ANBN01680 ANBN01682 ANBP01360 ANBR00553 ANBR00554 ANBR00555 ANBR00556 APKT00509 APKT00510 ANBM00705 ANBM00706 ANBM00707 ANBM00708 APKT03312 APKT0

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.

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