FDA Device recall Z-0092-2021
Servo-i Ventilator, Part No. 6487800, UDI Code 07325710000823 - Product Usage: intended for general and critical ventilator care, and it ca…
- FDA Device
- Class II
- ongoing
- Published 2020-10-21
On 2020-10-21 the FDA classified a Class II recall of Servo-i Ventilator, Part No. 6487800, UDI Code 07325710000823 - Product Usage: intended for general and critical ventilator care, and it ca… by Getinge Group Logistics America, citing A potentially shorter than specified nebulizer connector may result in difficulty in installing the Aeroneb Nebulizer module to the Servo-i device successfully.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0092-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-09-17 |
| Published | 2020-10-21 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Getinge Group Logistics America |
| Distribution | AZ, CA, GA, IL, MN, MO, NC, NJ, NY, RI, SC, TX, VA, WI, WV |
Product
Servo-i Ventilator, Part No. 6487800, UDI Code 07325710000823 - Product Usage: intended for general and critical ventilator care, and it can be used for low end to high end intensive care, in different configurations. It supports a variety of breathing modes and can be used for Neonates, Pediatric and Adults.
Reason
A potentially shorter than specified nebulizer connector may result in difficulty in installing the Aeroneb Nebulizer module to the Servo-i device successfully.
Identifiers
| code_info | Lot 6487800 Serial numbers 95160 95283 95284 95285 95286 95287 95288 95289 95290 95291 95292 95293 95294 95295 95…Lot 6487800 Serial numbers 95160 95283 95284 95285 95286 95287 95288 95289 95290 95291 95292 95293 95294 95295 95296 95297 95363 95364 95365 95366 95367 95368 95369 95370 95371 95372 95373 95374 95431 95432 95433 95374 95435 95436 95437 95438 95439 95440 95441 95442 95455 95456 95457 95458 95459 95460 95461 95462 95463 95464 95465 95466 95467 95468 95469 95470 95471 95472 95473 95474 95475 95476 95477 95478 95880 95881 95882 95883 95884 95885 95886 95887 95888 95889 95890 95891 95892 95893 95894 95895 95896 95897 95898 95899 95900 95901 95902 95903 95904 95905 95906 95907 95908 95909 95910 95911 95912 95913 95914 95915 95916 95917 95918 95919 95920 95921 95922 95923 95924 95925 95926 95927 95928 95929 95930 95931 95932 95933 95934 95935 95946 95947 96018 96019 96020 96021 96022 96023 96024 96025 96026 96027 96028 96029 96050 96051 96052 96053 96054 96055 96056 96057 96058 96059 96060 96061 96062 96063 96064 96065 96066 96067 96068 96069 96070 96071 96072 96073 9 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0092-2021%22
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