GE DATEX-OHMEDA AESTIVA/5 MRI ANESTHESIA SYSTEM— 510(k) K050055

Clearance details

Applicant

Datex-Ohmeda, Inc.

Product code

Code BSZ

Device class

Class 2

Regulation

21 CFR 868.5160

Advisory panel

Anesthesiology

Date received

2005-01-11

Decision date

2005-02-04

Decision

Substantially Equivalent

Clearance type

Special

Location

Madison, WI, US

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• K230931 — Atlan2023-07-23
• K213867 — Carestation 750/750c2023-03-28

• K254036 — Novii+ Wireless Patch System2026-08-10
• K260326 — Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)2026-07-28
• K251663 — Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)2025-10-22
• K213551 — Giraffe Omnibed Carestation CS12022-03-02
• K213553 — Giraffe Incubator Carestation CS12022-03-02

Death

23

Injury

298

Malfunction

32,987

Total

33,308

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0114-2020 — 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) 1006-9310-000-026571Class II·Terminated·GE Healthcare, LLC·20190719
• Z-0679-2016 — GE Healthcare, Aestiva MRI, 1006-9310-000. This version of the Datex-Ohmeda 7900 ventilator is used in Datex-Ohmeda Aestiva/5 anesthesia systems. It is a microprocessor based, electronically controlled, pneumatically driven ventilator that provides patient ventilation during surgical procedures. The Aestiva/5 MRI anesthesia system provides the functional feature set offered by the conventional Aestiva/5 to the clinician with the added ability to be used in the MR environment.Class II·Terminated·GE Medical Systems, LLC·20151215

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K050055.