Panels › Anesthesiology › Product code BSZ · Class 2
Gas-Machine, Anesthesia
Regulation 868.5160
2510(k)s in 12 months (189 all time)
12recalls in 12 months (177 all time)
161recalls that name a 510(k)
Top companies in BSZ
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 6, 2024 | Getinge Usa Sales Inc Flow-c Anesthesia System, model 6887700 Open, Classified |
BSZ | K133958 |
| Feb 6, 2024 | Getinge Usa Sales Inc Flow-i C40 Anesthesia System, model 6677400 Open, Classified |
BSZ | K133958 |
| Feb 6, 2024 | Getinge Usa Sales Inc Flow-i C30 Anesthesia System, model 6677300 Open, Classified |
BSZ | K133958 |
| Feb 6, 2024 | Getinge Usa Sales Inc Flow-i C20 Anesthesia System, model 6677200 Open, Classified |
BSZ | K133958 |
| Feb 1, 2024 | Draegerwerk Ag & Co. Kgaa Atlan, Gas Machine for Anesthesia or Analgesia, Catalog numbers 8621500 (Atlan A350) and
8621600 (Atlan A350 XL) Open, Classified |
BSZ | K230931 |
| Jan 26, 2023 | Getinge Usa Sales Inc Getinge Flow-e Anesthesia System, Part No. 6887900 Open, Classified |
BSZ | K191027 |
| Jan 26, 2023 | Getinge Usa Sales Inc Getinge Flow-c Anesthesia System, Part No. 6887700 Open, Classified |
BSZ | K191027 |
| Jan 26, 2023 | Getinge Usa Sales Inc Getinge Flow-i Anesthesia Systems
Flow-i C20, Part no. 6677200
Flow-i C30, Part no. 6677300
Flow-i C40, Part no. 6677400 Open, Classified |
BSZ | K191027 |
| Dec 7, 2022 | Getinge Usa Sales Inc Flow-c Anesthesia System (Product Code 6887700)
Flow-e Anesthesia System (Product Code 6887900) Open, Classified |
BSZ | K191027 |
| Jul 19, 2022 | GE Healthcare, LLC GE Healthcare Aisys CS2 Anesthesia System, Part number 1011-9050-000; and Avance CS2 and Avance CS2 Pro Anesthesia System, Part number 1009-9050-000. Terminated |
BSZ | K172045 |
| Jun 23, 2022 | Getinge Usa Sales Inc Flow-e Anesthesia System : Intended for use in administering anesthesia while controlling the entire ventilation of patient
Product Code/REF Number: 6887900 Terminated |
BSZ | K191027 |
| Jun 23, 2022 | Getinge Usa Sales Inc Flow-c Anesthesia System : intended for use in administering anesthesia while controlling the entire ventilation of patient
Product Code/REF Number: 6887700 Terminated |
BSZ | K191027 |
| May 27, 2022 | GE Healthcare, LLC GE Healthcare Avance CS2, Avance CS2 Pro Anesthesia Systems, Part #1009-9050-000; and Aisys CS2 Anesthesia Systems, Part # 1011-9050-000. Open, Classified |
BSZ | K172045 |
| Apr 25, 2022 | GE Healthcare, LLC Field replacement back up batteries distributed on or after April 1, 2019 for Avance CS2, Avance CS2 Pro, Avance, Amingo, Aespire View anesthesia devices Open, Classified |
BSZ | K172045 |
| Apr 25, 2022 | GE Healthcare, LLC Back up batteries in Avance CS2 and Avance CS2 Pro anesthesia devices manufactured
on or after April 1, 2019 Open, Classified |
BSZ | K172045 |
| Dec 16, 2021 | Draeger Medical, Inc. Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300 Terminated |
BSZ | K072884 |
| Dec 9, 2021 | Getinge Usa Sales Inc Vaporizer Sevoflurane Maquet Filling, Part No. 6886601
Component of the following systems:
Product Code(s) UPN/UDI:
Flow-c Anesthesia System 6887700 07325710009765
Flow-e Anesthesia System 6887900 0 Open, Classified |
BSZ | K191027 |
| Aug 2, 2021 | GE Healthcare, LLC Flow sensors that may be installed in the following GEHC anesthesia machines:
(1) Aestiva MRI, GTIN 0080682102339;
(2) Aestiva 7900;
(3) Aestiva 7100;
(4) Aespire System Carestation, S/5 Protiva Conf Open, Classified |
BSZ | K172045 |
| Aug 2, 2021 | GE Healthcare, LLC Flow sensors kept as stand-alone user replaceable spare parts for the GEHC anethesia machines:
2089610-001 FLOW SENSOR, LEGACY VAR ORF BCG (blue, cleanable)
2089610-001-S FLOW SENSOR, LEGACY VAR ORF Open, Classified |
BSZ | K172045 |
| Jan 29, 2021 | Getinge Group Logistics America, LLC Anesthesia gas-machine - Product Usage: intended for use in administering anesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in supporting patients Terminated |
BSZ | K191027 |
| Sep 17, 2020 | GE Healthcare, LLC Flow Sensor Service Part, Catalog 2096513-001-S Open, Classified |
BSZ | None listed |
| Sep 17, 2020 | GE Healthcare, LLC Flow Sensor Service Part, Catalog 2087640-001-S Open, Classified |
BSZ | None listed |
| Sep 17, 2020 | GE Healthcare, LLC Flow Sensor Service Part, Catalog 2089610-001-S Open, Classified |
BSZ | None listed |
| Sep 17, 2020 | GE Healthcare, LLC 9100c NXT system - Product Usage: Device is licensed and distributed outside of the US only. Open, Classified |
BSZ | K172045 |
| Sep 17, 2020 | GE Healthcare, LLC GE Datex-Ohmeda Aisys CS2 Anesthesia System - Product Usage: is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric adult). The d Open, Classified |
BSZ | K172045 |
| Sep 17, 2020 | GE Healthcare, LLC GE Datex-Ohmeda Avance CS2 Anesthesia System - Product Usage: intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The de Open, Classified |
BSZ | K172045 |
| Sep 17, 2020 | GE Healthcare, LLC Aestiva/5 MRI Anesthesia System - Product Usage: The Aestiva/5 MRI Anesthesia System provides the functional feature set offered by the conventional Aestiva/5 to the clinician with the added ability t Open, Classified |
BSZ | K172045 |
| Jan 23, 2020 | GE Healthcare, LLC Carestation 620/650/650c A2
Product Usage: anesthesia systems are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (pediatric and adult. Terminated |
BSZ | None listed |
| Jan 23, 2020 | GE Healthcare, LLC Carestation 620/650/650c A1
Product Usage: anesthesia systems are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (pediatric and adult. Terminated |
BSZ | K151570 |
| Jul 19, 2019 | GE Healthcare, LLC Aestiva 7100, Model Numbers:
1. 1006-9320-000
2. 1006-9321-000
3. 1006-9320-000-001101
4. 1006-9021-000
5. 1006-9012-000
6. 1006-9111-000
7. 1006-9321-000-007639
8. 1006-9321-000-000023
9. 1006-9321 Terminated |
BSZ | K000706 |
| Jul 19, 2019 | GE Healthcare, LLC Aespire 7100, Model Numbers:
1. 1009-9000-000-009469
2. 1009-9000-000
3. 1009-9000-000-013913
4. 1009-9000-000-001366
5. 1009-9000-000-009857
6. 1009-9003-000
7. 1009-9000-000-008120
8. 1009-9000-00 Terminated |
BSZ | K000706 |
| Jul 19, 2019 | GE Healthcare, LLC 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- Terminated |
BSZ | K050055 |
| Nov 9, 2018 | GE Healthcare, LLC Touchscreen display kit. Sold under the following product names: TOUCHSCREEN DISPLAY KIT 11.X ENGLISH FOR USA, TOUCHSCREEN DISPLAY KIT 11.X ENGLISH, TOUCHSCREEN DISPLAY KIT 11.X GERMAN,
TOUCHSCREEN Terminated |
BSZ | K110213 K170872 |
| Nov 9, 2018 | GE Healthcare, LLC Aisys CS2 Anesthesia System. Sold under the following product names: AISYS, AISYS 10.X TO 11.X UPGRADE KIT DUTCH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH FOR U Terminated |
BSZ | K110213 K170872 |
| Nov 9, 2018 | GE Healthcare, LLC Aisys Anesthesia System. Sold under the following product names: AISYS, AISYS 10.X TO 11.X UPGRADE KIT DUTCH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH FOR USA, Terminated |
BSZ | K110213 K170872 |
| Jul 24, 2018 | GE Medical Systems China Co., Ltd. GE 9100c NXT anesthesia systems Terminated |
BSZ | K151570 |
| Jul 24, 2018 | GE Medical Systems China Co., Ltd. GE Carestation 30 anesthesia systems Terminated |
BSZ | K151570 |
| Jul 24, 2018 | GE Medical Systems China Co., Ltd. GE Carestation 620/650/650c, A1 and A2 (non-US distribution) anesthesia systems Terminated |
BSZ | K151570 |
| May 24, 2018 | Draeger Medical, Inc. Perseus A500 Anesthesia Machine; Cat. no. MK06000
Product V
Product Usage:
Intended for use in anesthetizing adults, children, and neonates and can be used for automatic and manual ventilation, pres Terminated |
BSZ | K133886 |
| May 24, 2018 | Draeger Medical, Inc. Apollo Anesthesia Machine; Cat. no. 8605310
Product Usage:
Indicated as a continuous flow anesthesia system. The Apollo may be used for manually assisted or automatic ventilation, delivery of gases a Terminated |
BSZ | K081447 |
| May 24, 2018 | Draeger Medical, Inc. Fabius GS MRI Anesthesia Machine; Cat. no. 8607300
Product Usage:
Inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by Terminated |
BSZ | K072884 |
| May 24, 2018 | Draeger Medical, Inc. Fabius GS Tiro Anesthesia Machine; Cat. no. 8606000
Product Usage:
Inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied b Terminated |
BSZ | K042419 |
| May 24, 2018 | Draeger Medical, Inc. Fabius GS Premium Anesthesia Machine; Cat. no. 8607000
Product Usage:
Inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplie Terminated |
BSZ | K042419 |
| May 8, 2018 | Draeger Medical, Inc. Fabius Tiro M, anesthesia machine, catalog no. 8608400
Product Usage:
The products are inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O Terminated |
BSZ | K042419 |
| May 8, 2018 | Draeger Medical, Inc. Fabius Tiro, anesthesia machine, catalog no. 8606000
Product Usage:
The products are inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, Terminated |
BSZ | K042419 |
| May 8, 2018 | Draeger Medical, Inc. Fabius GS Premium, anesthesia machine, catalog no. 8607000
Product Usage:
The products are inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, Terminated |
BSZ | K042419 |
| May 8, 2018 | Draeger Medical, Inc. Fabius MRI, anesthesia machine, catalog no. 8607300
Product Usage:
The products are inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, a Terminated |
BSZ | K072884 |
| Nov 21, 2017 | Spacelabs Healthcare, Ltd. Arkon Anesthesia Delivery System, Model 99999, and software version 2.61 and upgrade kit 050-9043-00 Rev G.
The Spacelabs Arkon Anesthesia Workstation is intended for use in the hospital environment Terminated |
BSZ | K113051 |
| Oct 11, 2017 | GE Medical Systems China Co., Ltd. Carestation 620 A2, Carestation 650 A2, and Carestation 650c A2 Open, Classified |
BSZ | None listed |
| Oct 11, 2017 | GE Medical Systems China Co., Ltd. Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1 Open, Classified |
BSZ | K151570 |
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