FDAJuly 19, 2019device

Aespire 7100, Model Numbers: 1. 1009-9000-000-009469 2. 1009-9000-000 3. 1009-9000-000-013913 4. 1009-9000-000-001366 5. 1009-9000-000-009857 6. 1009-9003-000 7. 1009-9000-000-008120 8. 1009-9000-000-009600 9. 1009-9000-000-014290 10. 1009-9000-000-010585 11. 1009-9000-000-004993 12. 1009-9011-00...

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

100690120001006902100010069024000100690260001006903100010069111000100691140001006932000010099000000310099003000710099011000271009910100067

Recall history

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

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