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
FDA Recall Z-0114-2020 · Posted None
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Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeBSZ
Date Initiated2019-07-19
Date Terminated2026-04-13
Product Quantity502 devices
Reason for Recall
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.
Firm 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.
Root Cause
Software in the Use Environment
Distribution Pattern
Worldwide
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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