Recall Z-0114-2020 ยท BSZ Gas-Machine, Anesthesia
GE Healthcare, LLC
Aestiva MRI, Model Numbers: a) 1006-9310-000 b) 1006-9110-000 c) 1006-9023-000 d) 1006-9028-000 e) 1006-9310-000-305077 f) 1006-9310-000-015243 g) 1006-9310-000-017602 h) 1006-9310-000-103785 I) 1006-9310-000-025109 j) 1006-9310-000-009650 k) 1006-9310-000-015224 l) 1006-9310-000-031881 m) 1006-9310-000-031854 n) 1006-9310-000-026571
| 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 | 502 devices |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050055 | GE DATEX-OHMEDA AESTIVA/5 MRI ANESTHESIA SYSTEM Datex-Ohmeda, Inc., Feb 4, 2005 |