Servo-air Ventilator System-The Servo-air Ventilator System is: Intended for respiratory support, monitoring and treatme
Summary
The FDA issued a Class II for Servo-air Ventilator System-The Servo-air Ventilator System is: Intended for res by Getinge Usa Sales Inc. Reason: Device does not meet regulatory requirements of stability while stationary, which requires mechanical equipment, other than fixed mechanical equipment.
Details
Source
Device Recall
External ID
Z-1568-2022
Action Date
2022-08-31
Status
Ongoing
Category
device
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)
Lot/Code Info: 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
Quantity Affected: US 102 units; OUS 13750 units
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
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).
Type: Voluntary: Firm initiated
Recall Initiated: 2022-07-21
Company
Wayne, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 194 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Getinge Usa Sales Inc has 48 FDA actions in our database, including 48 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Getinge Usa Sales Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Getinge Usa Sales Inc have FDA actions?
Getinge Usa Sales Inc has 48 FDA actions in our database, including 48 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1568-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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