|
Device |
ventilator, continuous, facility use |
Product Code | CBK |
Regulation Number |
868.5895
|
Device Class |
2
|
MDR Year |
MDR Reports |
MDR Events |
2019 |
9100 |
9502 |
2020 |
11096 |
11096 |
2021 |
13322 |
13322 |
2022 |
15976 |
15976 |
2023 |
24956 |
24956 |
2024 |
17331 |
17331 |
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
Baxter Healthcare Corporation |
I |
Oct-22-2024 |
2 |
Baxter Healthcare Corporation |
I |
Jun-26-2024 |
3 |
Baxter Healthcare Corporation |
I |
Feb-24-2023 |
4 |
Breas Medical, Inc. |
II |
Apr-15-2022 |
5 |
Covidien |
I |
Aug-02-2024 |
6 |
Covidien Llc |
I |
Dec-09-2021 |
7 |
Covidien Llc |
II |
Nov-06-2020 |
8 |
Draeger Medical, Inc. |
I |
Aug-18-2023 |
9 |
Draeger Medical, Inc. |
I |
Jul-08-2023 |
10 |
Draeger Medical, Inc. |
I |
Feb-24-2023 |
11 |
Draeger Medical, Inc. |
II |
Apr-04-2022 |
12 |
Draeger Medical, Inc. |
II |
Oct-14-2021 |
13 |
Draeger Medical, Inc. |
II |
May-28-2021 |
14 |
GE Healthcare, LLC |
I |
Jun-06-2022 |
15 |
GE Healthcare, LLC |
II |
Aug-24-2020 |
16 |
GE Healthcare, LLC |
II |
Dec-17-2019 |
17 |
Getinge Group Logistics America, LLC |
II |
Oct-09-2020 |
18 |
Getinge Usa Sales Inc |
II |
Aug-24-2022 |
19 |
Getinge Usa Sales Inc |
I |
Aug-22-2022 |
20 |
Hamilton Medical AG |
I |
Jun-18-2024 |
21 |
Hamilton Medical AG |
II |
Apr-25-2023 |
22 |
Hamilton Medical AG |
II |
Nov-18-2022 |
23 |
Hamilton Medical AG |
I |
Aug-19-2022 |
24 |
Hamilton Medical AG |
I |
Jul-11-2019 |
25 |
Hamilton Medical, Inc. |
I |
Sep-20-2023 |
26 |
Hamilton Medical, Inc. |
I |
Jul-21-2023 |
27 |
Hill-Rom Manufacturing, Inc. |
II |
Nov-24-2020 |
28 |
Medtronic formerly Covidien |
I |
Apr-25-2022 |
29 |
NIHON KOHDEN ORANGEMED, INC |
II |
Sep-08-2021 |
30 |
Percussionaire Corporation |
I |
Jan-17-2024 |
31 |
Percussionaire Corporation |
I |
Jan-17-2024 |
32 |
Percussionaire Corporation |
II |
Nov-07-2023 |
33 |
Philips Respironics, Inc. |
I |
Sep-05-2024 |
34 |
Philips Respironics, Inc. |
I |
Apr-17-2024 |
35 |
Philips Respironics, Inc. |
II |
Jan-04-2024 |
36 |
Philips Respironics, Inc. |
II |
Jul-07-2023 |
37 |
Philips Respironics, Inc. |
I |
Jun-02-2023 |
38 |
Philips Respironics, Inc. |
I |
Apr-03-2023 |
39 |
Philips Respironics, Inc. |
I |
Jan-06-2023 |
40 |
Philips Respironics, Inc. |
I |
Mar-18-2022 |
41 |
Philips Respironics, Inc. |
I |
Jan-22-2022 |
42 |
Philips Respironics, Inc. |
II |
Aug-13-2021 |
43 |
Philips Respironics, Inc. |
I |
Jul-15-2021 |
44 |
Philips Respironics, Inc. |
I |
Feb-15-2020 |
45 |
ResMed Ltd. |
I |
Oct-23-2023 |
46 |
Ventec Life Systems, Inc. |
I |
Feb-23-2024 |
47 |
Ventec Life Systems, Inc. |
II |
Jun-21-2021 |
48 |
Vyaire Medical |
II |
Jun-15-2023 |
49 |
Vyaire Medical |
I |
Feb-16-2022 |
50 |
Vyaire Medical |
II |
Mar-04-2020 |
51 |
ZOLL Medical Corporation |
I |
Jun-20-2024 |
|
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