Recall Z-0116-2020 ยท BSZ Gas-Machine, Anesthesia
GE Healthcare, LLC
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. 1009-9011-000-004795 13. 1009-9000-000-013407 14. 1009-9000-000-004604 15. 1009-9000-000-017674 16. 1009-9000-000
| Date | Jul 19, 2019 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software in the Use Environment |
| Action | The firm sent an urgent medical device correction notice to their consignees by letter on 07/19/2019. The letter explained the issue and requested that the consignee ensure that the devices are connected to a sufficiently secure terminal server. |
| Quantity | 19351 devices |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K000706 | DATEX-OHMEDA AESTIVA/5 WITH 7100 VENTILATOR Datex-Ohmeda, Inc., May 11, 2000 |