Recall Z-0117-2020 ยท BSZ Gas-Machine, Anesthesia
GE Healthcare, LLC
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. 1006-9321-000-009266 14. 1006-9321-000-008526 15. 1006-9321-000-116507 16. 1006-9321-000-009244 17. 1006-9321
| 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 | 473 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 |