Servo-air Ventilator System-The Servo-air Ventilator System is:… — Class II medical device recall Z-1568-2022
Ongoing recall by Getinge Usa Sales Inc, reported 2022-08-31, distributed nationwide. Device does not meet regulatory requirements of stability while stationary, which requires mechanical equipmen
| Recall number | Z-1568-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Getinge Usa Sales Inc, Wayne, NJ, United States |
| Recall initiated | 2022-07-21 |
| Classified | 2022-08-24 |
| Reported by FDA | 2022-08-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BR, CH, CN, EG, HK, IL, JP, KR, MX, PK, SA, TR, TW, ZA |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 07325710003114 |
| Serial numbers | 10558, 10561, 10567, 10569, 10573, 10575, 10579, 10580, 10585, 10586, 12287, 12347, 12348, 12349, 12350, 12351, 12352, 12353, 12354, 12355, 20116, 20117, 20118, 20119, 20120 and 130 more |
| Model numbers | 6882000 |
Product
Servo-air Ventilator System-The Servo-air Ventilator System is: Intended for respiratory support, monitoring and treatment of pediatric and adult patients. Model Number: 6882000 (equipped with 6881999 mobile cart)
Reason for recall
Device does not meet regulatory requirements of stability while stationary, which requires mechanical equipment, other than fixed mechanical equipment, that is intended to be used on the floor or on a table shall be permanently marked with a clearly legible warning of this risk
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1568-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.