GE Healthcare Aisys CS2 Anesthesia System, Part number 1011-9050-000; and Avance CS2 and Avance C...
FDA Device Recall #Z-1389-2022 — Class I — June 1, 2022
Recall Summary
| Recall Number | Z-1389-2022 |
| Classification | Class I — Serious risk |
| Date Initiated | June 1, 2022 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | GE Healthcare, LLC |
| Location | Waukesha, WI |
| Product Type | Devices |
| Quantity | 5,372 devices |
Product Description
GE Healthcare Aisys CS2 Anesthesia System, Part number 1011-9050-000; and Avance CS2 and Avance CS2 Pro Anesthesia System, Part number 1009-9050-000.
Reason for Recall
There is a potential reversal of the O2 and air cylinder pressure transducer connections.
Distribution Pattern
Worldwide Distribution. US nationwide, Australia, Austria, Belgium, Bolivia, Brazil, Canada, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Italy, Japan, Kenya, Korea, Kuwait, Malaysia, Mexico, Montenegro, Nepal, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and Uruguay.
Lot / Code Information
Aisys CS2 - GTIN 00840682102292 Serial numbers starting with APWA: 00101 through 00176, 00185 through 00697, 00700 through 00763, 00768 through 01013, 01016 through 01216, 01218 through 01223, 01225 through 01596, 01601 through 01683, 01685 through 01805, 01808 through 01960, 01964 through 01999, 02003 through 02021, 02026 through 02168, 02175, 02182 through 02308, 02311 through 02361, 02376 through 02405, 02424 through 02429, 02450 through 02456, 02519 through 02531, 02533 through 02539. Serial numbers starting with APWB: 00101 through 00151, 00154, 00155, 00162, 00163, 00169 through 00199, 00201 through 00336, 00338 through 00373, 00378 through 00644, 00647 through 00684, 00686 through 00689, 00691 through 00743, 00746 through 00750, 00754 through 00756, 00770 through 00818, 00823 through 00828, 00838 through 00842, 00905 through 00931, 00944 through 00952. Serial numbers starting with APWZ: 03034 through 03037, 03053 through 03056, 03060, 03062 through 03066, 03071 through 03075, 03164 through 03171, 03311 through 03314, 03319, 03320, 03381 through 03415, 03420 through 03422. Avance CS2 and Avance CS2 Pro - GTIN: 00840682102322, Serial numbers starting with APKA: 00101 through 00105, 00107 through 00165, 00167 through 00176, 00178 through 00218, 00220 through 00767, 00776 through 00836, 00838 through 01081, 01084 through 01150, 01152 through 01467, 01469 through 01532, 01537 through 01541, 01543 through 01809, 01811 through 01894, 01921 through 01961, 01965 through 01985, 02009 through 02013, 02016 through 02029. Serial numbers starting with APKB: 00101 through 00108, 00110 through 00121, 00123 through 00265, 00269 through 00293, 00295 through 00417, 00422 through 00438, 00441 through 00452, 00462, 00464 through 00473, 00478, 00480 through 00487, 00490 through 00492, 00495 through 00513, 00515 through 00517. Serial numbers APKZ00247, 00506, 02331, 02336, 02337, 02510 through 02569.
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.