Carestation 650
Carestation 650: 1 catalogue number listed by Datex-Ohmeda, Inc., United States, under Gas-Machine, Anesthesia. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
1catalogue number
24510(k) clearances naming this product code
14recalls on this code
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1), Hebei (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beijing Aeonmed Co., Ltd. | Sanhe | Hebei | Contract manufacturer | 7 |
| Shenzhen Prunus Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 1 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
Record
| Listed by | Datex-Ohmeda, Inc., United States |
|---|---|
| FDA product code | BSZ |
| Device type | Gas-Machine, Anesthesia |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5160 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K151570 |
| Record published | 2016-02-12 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment atmospheric pressure 56.66 to 106.66 KiloPascal; Storage environment temperature -25 to 60 °C; Storage environment humidity 15 to 95 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| A9800 Anesthesia Workstation | Oricare Inc. | 22 |
| Analgesia GAS Mixer, Digital MDM Delivery System | Parker Hannifin Corp. | 12 |
| Aladin2 | Datex-Ohmeda, Inc. | 12 |
| Penlon | Penlon Ltd. | 7 |
| Analgesia GAS Mixer, MDM Delivery System | Parker Hannifin Corp. | 6 |
| Codonics SLS500i Operating Software | Codonics, Inc. | 4 |
| Codonics Safe Label System®(SLS) 500i Point of Care Station | Codonics, Inc. | 4 |
| Spacelabs Healthcare | Spacelabs Healthcare (Washington), Inc | 4 |
| Codonics Safe Label System®(SLS) 550i Point of Care Station – 144C | Codonics, Inc. | 3 |
| Aestiva | Datex-Ohmeda, Inc. | 2 |
| Aisys | Datex-Ohmeda, Inc. | 2 |
| Infinium Medical Inc. | Infinium Medical, Inc. | 2 |
Showing 12 of 293. All products under Gas-Machine, Anesthesia
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K213867 | 2023-03-28 |
| K172045 | 2017-11-03 |
| K170872 | 2017-08-15 |
| K151570 | 2016-01-21 |
| K143530 | 2015-04-24 |
| K132530 | 2013-12-20 |
| K131945 | 2013-08-08 |
| K123125 | 2013-02-06 |
| K122445 | 2012-10-12 |
| K112722 | 2011-12-16 |
| K110213 | 2011-07-20 |
| K090233 | 2009-03-05 |
| K081844 | 2008-08-29 |
| K073707 | 2008-01-30 |
| K071142 | 2007-06-06 |
| K061609 | 2006-06-27 |
| K050676 | 2005-04-12 |
| K050626 | 2005-03-25 |
| K050055 | 2005-02-04 |
| K042154 | 2004-08-31 |
| K040743 | 2004-04-22 |
| K032803 | 2004-03-10 |
| K000706 | 2000-05-11 |
| K993410 | 2000-04-25 |
Recalls Naming This Product
14 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| GE Medical Systems (China) Co., Ltd. | 510(k) number | 2025-11-14 | Class I | Component change control | 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 failure. Anesthesia systems only operat | 1277 units | |
| GE Medical Systems (China) Co., Ltd. | 510(k) number | 2025-11-14 | Class I | Component change control | 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 failure. Anesthesia systems only operat | 203 units | |
| GE Medical Systems (China) Co., Ltd. | 510(k) number | 2025-03-21 | Class I | Device Design | Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilati | 2298 units | |
| GE Medical Systems (China) Co., Ltd. | 510(k) number | 2025-03-21 | Class I | Device Design | Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilati | 383 units | |
| GE Medical Systems (China) Co., Ltd. | 510(k) number | 2025-03-21 | Class I | Device Design | Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilati | 4036 units | |
| GE Medical Systems (China) Co., Ltd. | 510(k) number | 2025-03-21 | Class I | Device Design | Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilati | 648 units | |
| GE Medical Systems (China) Co., Ltd. | 510(k) number | 2025-03-21 | Class I | Device Design | Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilati | 69 units | |
| GE Medical Systems (China) Co., Ltd. | 510(k) number | 2025-03-21 | Class I | Device Design | Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilati | 19 units | |
| GE Medical Systems, LLC | 510(k) number | 2019-11-25 | Class I | Process control | 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 will provide high priority audio and vis | 3319 units | 2023-11-30 |
| GE Medical Systems (China) Co., Ltd. | 510(k) number | 2018-07-24 | Class II | Nonconforming Material/Component | 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 equipped with the Aux O2 + Air functio | 310 units | 2020-12-16 |
| GE Medical Systems (China) Co., Ltd. | 510(k) number | 2018-07-24 | Class II | Nonconforming Material/Component | 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 equipped with the Aux O2 + Air functio | 252 units | 2020-12-16 |
| GE Medical Systems (China) Co., Ltd. | 510(k) number | 2018-07-24 | Class II | Nonconforming Material/Component | 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 equipped with the Aux O2 + Air functio | 401 units | 2020-12-16 |
| GE Medical Systems (China) Co., Ltd. | 510(k) number | 2017-10-11 | Class II | Other | Possible incomplete seal between the CO2 absorber and the breathing circuit CO2 bypass port assembly of the Carestation 600 Series systems. | 5,148 devices | |
| GE Medical Systems, LLC | 510(k) number | 2017-05-02 | Class II | Device Design | Carestation 620, 650 and 650c has Potential for Elevated FiCO2 and Unexpected System Malfunction | 3,448 (334 US; 3,114 OUS) | 2018-02-13 |
Recalls
9 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2026-07-30 | Not classified | Nonconforming Material/Component | Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 control, the system delivers 100% O2 to the breathing system enabling continued controlled | 140 units | |
| 2026-07-30 | Not classified | Nonconforming Material/Component | Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 control, the system delivers 100% O2 to the breathing system enabling continued controlled | 7 units | |
| 2026-07-30 | Not classified | Nonconforming Material/Component | Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 control, the system delivers 100% O2 to the breathing system enabling continued controlled | 410 units | |
| 2026-07-30 | Not classified | Nonconforming Material/Component | Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 control, the system delivers 100% O2 to the breathing system enabling continued controlled | 475 units | |
| 2024-07-12 | Class I | Device Design | Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port. | 649 units | |
| 2024-07-12 | Class I | Device Design | Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port. | ||
| 2024-07-12 | Class I | Device Design | Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port. | 9,349 units | |
| 2024-07-12 | Class I | Device Design | Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port. | 15,739 units | |
| 2024-07-12 | Class I | Device Design | Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port. | 12,036 units | |
| 2024-07-12 | Class I | Device Design | Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port. | 10,338 units | |
| 2024-07-12 | Class I | Device Design | Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port. | 20,097 units | |
| 2024-07-12 | Class I | Device Design | Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port. | 4,790 units | |
| 2024-07-12 | Class I | Device Design | Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port. | 12,559 units | |
| 2008-08-28 | Not classified | Manufacturing material removal | The electronic vaporization system in the GE Aisys Anesthesia machine contains the following components: Backpressure Valve, Inflow Check Valve and Cassette Interface Board, that can contribute to independent failures. | 1571 | 2016-03-08 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.