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U.S. Department of Health and Human Services

Class 2 Device Recall BetaMAQUET

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 Class 2 Device Recall BetaMAQUETsee related information
Date Initiated by FirmOctober 14, 2022
Date PostedNovember 15, 2022
Recall Status1 Open3, Classified
Recall NumberZ-0239-2023
Recall Event ID 91018
Product Classification Table, operating-room, ac-powered - Product Code FQO
ProductExtension Tabletop for Operating Table System 1140, Model Nos. 1140.20F0 and 1140.20AN
Code Information No UDI - product discontinued in 2008. Part Number 1140.20F0: Serial Nos. 3, 8, 9, 10 Part Number 1140,20AN: Serial No. 851
FEI Number 3013876692
Recalling Firm/
Manufacturer		 Getinge Usa Sales Inc
1 Geoffrey Way
Wayne NJ 07470-2035
For Additional Information ContactStephanie Moretti
973-709-7170
Manufacturer Reason
for Recall		The back rest may unintentionally drop suddenly, resulting in adverse health consequences if a patient were to fall on the floor head first and at a steep angle.
FDA Determined
Cause 2		Equipment maintenance
ActionOn October 14, 2022, the firm notified affected customers through Urgent Medical Device Correction letters. Customers were provided with extra precautions to take in order to continue use of the device. If you have any questions, please contact your Getinge representative or call the Getinge Customer Support at (888) 943-8872 (select option 2), Monday through Friday, 8AM - 6PM ET.
Quantity in Commerce5 US; 1008 OUS
DistributionWorldwide - US Nationwide distribution in the states of MA, NJ, SC, and TN. The countries of Australia (AU), Austria (AT), Belgium (BE), Brazil (BR), Bulgaria (BG), Canada (CA), China (CN), Croatia (HR), Czech Republic (CZ), Denmark (DK), Estonia (EE), Finland (FI), France (FR), Germany (DE), Greece (GR), Hungary (HU), Indonesia (ID), Israel (IL), Italy (IT), Japan (JP), Jordan (JO), Kuwait (KW), Lithuania (LT), Luxembourg (LU), Mexico (MX), Montenegro (ME), Morocco (MA), Netherlands (NL), Norway (NO), Pakistan (PK), Peru (PE), Poland (PL), Portugal (PT), Romania (RO), Russia (RU), Saudi Arabia (SA), Slovenia (SI), South Korea (KR), Spain (ES), Sweden (SE), Switzerland (CH), Taiwan (TW), Thailand (TH), Tunisia (TN), Turkey (TR), United Arab Emirates (AE), United Kingdom (GB), Yemen (YE).
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.
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