Reported Dec 25, 2019 · Terminated
Aestiva 7100, Model Numbers: 1. 1006-9320-000 2. 1006-9321-000 3. 1006-9320-000-001101 4. 1006-9021-000 5.…
GE Healthcare, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
134 of 134 products
| Model / number | Product as published |
|---|---|
1006-9320-000 | Aestiva 7100, Model Numbers: 1. |
1006-9321-000 | 2. |
1006-9320-000-001101 | 3. |
1006-9021-000 | 4. |
1006-9012-000 | 5. |
1006-9111-000 | 6. |
1006-9321-000-007639 | 7. |
1006-9321-000-000023 | 8. |
1006-9321-000-015180 | 9. |
1006-9320-000-010369 | 10. |
1006-9321-000-019486 | 11. |
1006-9321-000-007601 | 12. |
1006-9321-000-009266 | 13. |
1006-9321-000-008526 | 14. |
1006-9321-000-116507 | 15. |
1006-9321-000-009244 | 16. |
1006-9321-000-012769 | 17. |
1006-9320-000-004497 | 18. |
1006-9320-000-009697 | 19. |
1006-9320-000-014484 | 20. |
- Lot codes and dates
- Model, Catalogue or Code # Mfg. Lot or Serial #
946 of 946 codes
1006-9012-000AMVE002531006-9021-000AMVH001921006-9024-000AMVD001151006-9026-000AMVE005511006-9031-000AMVE002031006-9111-000AMVF012371006-9114-000AMVF001901006-9320-000AMVF013051006-9320-000-000001AMVJ002231006-9320-000-000473AMVH007711006-9320-000-000581AMVJ002391006-9320-000-000607AMVJ002351006-9320-000-001101AMVH007721006-9320-000-001211AMVJ002641006-9320-000-002141AMVJ003361006-9320-000-002316AMVJ003441006-9320-000-002368AMVH007781006-9320-000-002450AMVJ002541006-9320-000-002634AMVH007741006-9320-000-003359AMVJ003161006-9320-000-003863AMVJ003781006-9320-000-004311AMVJ003741006-9320-000-004497AMVJ004081006-9320-000-004596AMVJ008221006-9320-000-004623AMVK005261006-9320-000-005394AMVJ004601006-9320-000-005531AMVJ004861006-9320-000-005677AMVJ004621006-9320-000-005868AMVH007771006-9320-000-006392AMVJ00489
- Model, Catalogue or Code # Mfg. Lot or Serial #
- Amount recalled
- 473 devices
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Why it was recalled
Certain Aespire and Aestiva Anesthesia Systems were noted to have a vulnerability to a cyber-attack when connected to the hospital network. An insufficiently secured terminal server may provide an opportunity for a malicious actor that has already penetrated the hospital network to send fraudulent flow sensor correction parameters.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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