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U.S. Department of Health and Human Services

Class 2 Device Recall Getinge

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 Class 2 Device Recall Getingesee related information
Date Initiated by FirmJuly 21, 2022
Create DateAugust 24, 2022
Recall Status1 Open3, Classified
Recall NumberZ-1568-2022
Recall Event ID 90648
510(K)NumberK192604 
Product Classification Ventilator, continuous, facility use - Product Code CBK
ProductServo-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)
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
Recalling Firm/
Manufacturer		 Getinge Usa Sales Inc
1 Geoffrey Way
Wayne NJ 07470-2035
Manufacturer 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
FDA Determined
Cause 2		Device Design
ActionMaquet Critical Care AB/Getinge issued Urgent Medical Device Correction letter to US consignees on 7/21/22 for delivery on Monday, July 25th via FedEX. If you have a Servo-air Ventilator System with one or more of the serial numbers listed on page 1 of this notification, a Getinge trained or authorized service technician will affix Symbol, ISO 7010:P019 "Do not step", (according to IEC 60601-1) to your Servo-air Ventilator system. Letter states reason for recall, health risk and action to take: 1. Please examine your inventory immediately to determine if you have received any Servo-air Ventilator devices with one of the affected serial numbers. 2. If you have a Servo-air Ventilator device affected by this field correction, please complete and sign the attached MEDICAL DEVICE CORRECTION - RESPONSE FORM (page 6). Your affected device/(s) will be corrected during your next planned maintenance or other service visit. However, if you do not maintain a service contract with Getinge, you may contact Getinge to arrange a visit by a Getinge trained or authorized service technician by contacting Getinge Tech Support at (888) 9GETUSA / (888) 943-8872 (select option 4, then option 2), between the hours of 8:00 a.m. and 6:00 p.m. Eastern Standard Time. This correction will be performed at no cost to your facility. 3. Please return the completed form to Getinge by emailing a scanned copy to Servoair2022.us@getinge.com or by faxing the form to 1(973) 860-2462. 4. Whether or not you have affected product(s) with the serial numbers listed in this notice, please complete and sign the attached MEDICAL DEVICE CORRECTION - RESPONSE FORM (page 6) to acknowledge that you have received this notification, per the instruction in number 3 above. 5. Please forward this information to all current and potential Servo-air Ventilator System users within your hospital/facility. 6. If you are a distributor who has shipped any affected products to customers, please forward this document to t
Quantity in CommerceUS 102 units; OUS 13750 units
DistributionWorldwide 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).
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = CBK
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