FDAJuly 19, 2019device

Aestiva 7100, Model Numbers: 1. 1006-9320-000 2. 1006-9321-000 3. 1006-9320-000-001101 4. 1006-9021-000 5. 1006-9012-000 6. 1006-9111-000 7. 1006-9321-000-007639 8. 1006-9321-000-000023 9. 1006-9321-000-015180 10. 1006-9320-000-010369 11. 1006-9321-000-019486 12. 1006-9321-000-007601 13. 1006-932...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

ge healthcare

UPCs

10069012000100690210001006902400010069026000100690310001006911100010069114000100693200001006932100010069322000100693200002100693210003

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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