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Servo-air Ventilator System-The Servo-air Ventilator System is: Intended for respiratory support,...

FDA Device Recall #Z-1568-2022 — Class II — July 21, 2022

Recall Summary

Recall Number Z-1568-2022
Classification Class II — Moderate risk
Date Initiated July 21, 2022
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Getinge Usa Sales Inc
Location Wayne, NJ
Product Type Devices
Quantity US 102 units; OUS 13750 units

Product Description

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

Distribution Pattern

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).

Lot / Code Information

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

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Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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