# K151570: Carestation 620/650/650C

- Pathway: 510(k) (Traditional)
- Applicant: Datex-Ohmeda, Inc.
- Decided: Jan 21, 2016 after 225 days
- Product code: BSZ (Gas-Machine, Anesthesia)
- Device class: 2
- Regulation: 21 CFR 868.5160
- Recalls of this device: 14 (9 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K902859 (1991). 86 ancestors in all.
1 later device descends from it; 1 cites it directly.
10 of 88 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131945: GE Datex-Ohmeda Avance CS2, Datex-Ohmeda (2013) Summary page 4.

## Most influential descendants
- K213867: Carestation 750/750c (2023), 0 descendants of its own

## Recalls of this device
- Nov 14, 2025 · Class I · Z-0913-2026: Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in the event of an AC mains power f
- Nov 14, 2025 · Class I · Z-0915-2026: Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in the event of an AC mains power f
- Mar 21, 2025 · Class I · Z-1627-2025: GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these 
- Mar 21, 2025 · Class I · Z-1632-2025: GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these 
- Mar 21, 2025 · Class I · Z-1624-2025: GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these 
- Mar 21, 2025 · Class I · Z-1628-2025: GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these 
- Mar 21, 2025 · Class I · Z-1631-2025: GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these 
- Mar 21, 2025 · Class I · Z-1634-2025: GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these 
- Nov 25, 2019 · Class I · Z-0813-2020: GE Healthcare has become aware that there is a potential for a loose cable connection inside specific manufactured anesthesia devices. This would cause a loss of mechanical ventilation and the system 
- Jul 24, 2018 · Class II · Z-2955-2018: On systems equipped with the Auxiliary Common Gas Outlet (ACGO), there is a potential for the auxiliary gas switch to unexpectedly switch from the ACGO position back to the circle position. On systems
- Jul 24, 2018 · Class II · Z-2954-2018: On systems equipped with the Auxiliary Common Gas Outlet (ACGO), there is a potential for the auxiliary gas switch to unexpectedly switch from the ACGO position back to the circle position. On systems
- Jul 24, 2018 · Class II · Z-2956-2018: On systems equipped with the Auxiliary Common Gas Outlet (ACGO), there is a potential for the auxiliary gas switch to unexpectedly switch from the ACGO position back to the circle position. On systems
- Oct 11, 2017 · Class II · Z-0579-2018: Possible incomplete seal between the CO2 absorber and the breathing circuit CO2 bypass port assembly of the Carestation 600 Series systems.
- May 2, 2017 · Class II · Z-2703-2017: Carestation 620, 650 and 650c has Potential for Elevated FiCO2 and Unexpected System Malfunction

## Indications for use
The Carestation 620/650/650c anesthesia systems are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (pediatric, and adult). The anesthesia systems are suitable for use in a patient environment, such as hospitals, surgical centers, or clinics. The systems are intended to be operated by a clinician qualified in the administration of general anesthesia.

Source page: https://510kreport.com/device/K151570
Methodology: https://510kreport.com/methodology