Aladin2
12 catalogue numbers from SEV EASY-FIL A, 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
12catalogue numbers in this listing
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) | K132530 |
| Record published | 2015-09-23 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Storage environment humidity 15 to 95 % RH; Storage environment atmospheric pressure 56.66 to 106.66 KiloPascal; Storage environment temperature -25 to 50 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SEV EASY-FIL A | In distribution | |
| SEV QUIK-FIL | In distribution | |
| SEV EASY-FIL B | In distribution | |
| SEV EASY-FIL | In distribution | |
| SEV CLOSED-FILL | In distribution | |
| DES SAF-FIL | In distribution | |
| SEV QUIK-FIL A | In distribution | |
| SEV CLOSED-FILL | In distribution | |
| ISO EASY-FIL | In distribution | |
| ENF EASY-FIL | In distribution | |
| DES SAF-FIL B | In distribution | |
| DES FIXED-FIL | 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 |
| 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 |
| Aespire | Datex-Ohmeda, 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
7 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, LLC | 510(k) number | 2018-09-27 | Class II | Software design | Upgraded Aisys anesthesia devices and Aisys CS2 anesthesia devices with PSVPro Spontaneous Breathing Modes do not provide the PSVPro ventilation mode feature of transitioning to SIMV PCV backup ventilation mode. PSVPro Spontaneous Breathing | 4,207 units total | 2021-04-12 |
| GE Medical Systems, LLC | 510(k) number | 2018-09-27 | Class II | Software design | Upgraded Aisys anesthesia devices and Aisys CS2 anesthesia devices with PSVPro Spontaneous Breathing Modes do not provide the PSVPro ventilation mode feature of transitioning to SIMV PCV backup ventilation mode. PSVPro Spontaneous Breathing | 4,207 units total | 2021-04-12 |
| GE Medical Systems, LLC | 510(k) number | 2018-09-27 | Class II | Software design | Upgraded Aisys anesthesia devices and Aisys CS2 anesthesia devices with PSVPro Spontaneous Breathing Modes do not provide the PSVPro ventilation mode feature of transitioning to SIMV PCV backup ventilation mode. PSVPro Spontaneous Breathing | 4,207 units total | 2021-04-12 |
| GE Medical Systems, LLC | 510(k) number | 2017-10-04 | Class II | Process control | Non-Conforming devices were shipped from the service center without proper evaluation and therefore may be nonconforming. | 2 | 2020-04-10 |
| GE Medical Systems, LLC | 510(k) number | 2016-03-15 | Class II | Employee error | The vacuum suction tubing could be kinked within the machine resulting in suction less than the 20 lpm required by ISO 10079-3. This could result in inadequate suction performance to clear the airway and inadequate ventilation of the patien | 952 (488 US; 464 OUS) | 2016-11-07 |
| GE Medical Systems, LLC | 510(k) number | 2016-02-17 | Class II | Nonconforming Material/Component | GE Healthcare has recently become aware of a potential safety issue involving a momentary, self-correcting anesthetic agent bolus when using 21% oxygen on all Aisys CS2 and upgraded Aisys anesthesia devices. | 5496 | 2018-09-04 |
| GE Medical Systems, LLC | 510(k) number | 2015-12-15 | Class II | Nonconforming Material/Component | The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open position, which could cause pressure to build in the mechanical ventilation cycle. If this issue is left unresolved, it could result in excessive or | 2627 | 2016-09-21 |
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.