Extension Tabletop for Operating Table System 1140, Model Nos. 1140.20F0 and 1140.20AN
Summary
The FDA issued a Class II for Extension Tabletop for Operating Table System 1140, Model Nos. 1140.20F0 and 114 by Getinge Usa Sales Inc. Reason: 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 s.
Details
Source
Device Recall
External ID
Z-0239-2023
Action Date
2022-11-23
Status
Ongoing
Category
device
Product Description
Extension Tabletop for Operating Table System 1140, Model Nos. 1140.20F0 and 1140.20AN
Lot/Code Info: No UDI - product discontinued in 2008. Part Number 1140.20F0: Serial Nos. 3, 8, 9, 10 Part Number 1140,20AN: Serial No. 851
Quantity Affected: 5 US; 1008 OUS
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.
Distribution
Worldwide - 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).
Type: Voluntary: Firm initiated
Recall Initiated: 2022-10-14
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 171 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-0239-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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