Recall archive / FDA device enforcement
Servo-air Ventilator System-The Servo-air Ventilator System is: Intended for respiratory support, monitoring and trea... — FDA record Z-1568-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jul 21, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- 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
- Classification
- Class II
- Recalling firm
- Getinge Usa Sales Inc
- Quantity
- US 102 units; OUS 13750 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1568-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI: 07325710003114 Serial Numbers: 10558 12349 20122 20135 20148 21704 23177 23169 23430 23652 23749 23762 10561 12350 20123 20136 20150 21705 23178 23171 23431 23653 23750 23763 10567 12351 20124 20137 20151 21706 23179 23188 23432 23654 23751 23857 10569 12352 20125 20138 20153 21707 23180 23375 23429 23655 23752 23858 10573 12353 20126 20139 20155 22206 23183 23376 23536 23656 23753 23973 10575 12354 20127 20140 20149 22551 23185 23377 23537 23657 23754 23974 10579 12355 20128 20141 20152 22552 23187 23422 23538 23658 23755 23975 10580 20117 20129 20142 20156 22865 23294 23423 23539 23659 23756 24013 10585 20116 20130 20143 20157 23181 23164 23424 23563 23660 23757 24014 10586 20118 20131 20144 20300 23176 23165 23425 23551 23661 23758 24015 12287 20119 20132 20145 20529 23184 23166 23426 23552 23697 23759 24016 12347 20120 20133 20146 21702 23128 23167 23427 23650 23698 23760 24017 12348 20121 20134 20147 21703 23175 23168 23428 23651 23699 23761 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution - US Nationwide and the countries of Australia (AU), Brazil (BR), China (CN), Egypt (EG), EEA, Hong Kong (HK), Israel (IL), Japan (JP), Mexico (MX), Pakistan (PK), Saudi Arabia (SA), South Africa (ZA), South Korea (KR), Switzerland (CH), Taiwan (TW), Turkey (TR), and United Arab Emirates (AE).
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Aug 31, 2022
- Recall initiation date
- Jul 21, 2022
- Center classification date
- Aug 24, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.