Getinge Usa Sales Inc

Complete recall history across all FDA and CPSC categories — 48 total recalls

Getinge Usa Sales Inc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (48)

FDA medical device enforcement actions by Getinge Usa Sales Inc

Date Product Reason Class
Jan 15, 2025 Vaporizer Sevoflurane, Quik-Fil. Model Number: 6682285. Device is a componen... Sevoflurane used with the vaporizer may degrade to hydrogen fluoride, which c... Class I
Oct 3, 2024 MEERA CL mobile operating table - Designed for the placement and positioning ... Error code "50037" occurs on the IR-Hand Control when a MEERA-table is contro... Class II
Oct 3, 2024 MEERA CL mobile operating table - Designed for the placement and positioning ... Error code "50037" occurs on the IR-Hand Control when a MEERA-table is contro... Class II
Oct 3, 2024 MEERA CL mobile operating table - Designed for the placement and positioning ... Error code "50037" occurs on the IR-Hand Control when a MEERA-table is contro... Class II
Oct 3, 2024 MEERA CL mobile operating table - Designed for the placement and positioning ... Error code "50037" occurs on the IR-Hand Control when a MEERA-table is contro... Class II
Oct 3, 2024 MEERA CL mobile operating table - Designed for the placement and positioning ... Error code "50037" occurs on the IR-Hand Control when a MEERA-table is contro... Class II
Oct 3, 2024 MEERA CL mobile operating table - Designed for the placement and positioning ... Error code "50037" occurs on the IR-Hand Control when a MEERA-table is contro... Class II
Oct 3, 2024 MEERA CL mobile operating table - Designed for the placement and positioning ... Error code "50037" occurs on the IR-Hand Control when a MEERA-table is contro... Class II
Oct 3, 2024 MEERA CL mobile operating table - Designed for the placement and positioning ... Error code "50037" occurs on the IR-Hand Control when a MEERA-table is contro... Class II
May 29, 2024 ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322B5 The recall is prompted by a defective charger unit (0970.2873) for models 113... Class II
May 29, 2024 ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322F5 The recall is prompted by a defective charger unit (0970.2873) for models 113... Class II
May 29, 2024 ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322B4 The recall is prompted by a defective charger unit (0970.2873) for models 113... Class II
May 1, 2024 Vaporizer Sevoflurane Maquet Filling, Product code/REF number (6682282), Comp... Sevoflurane used with the vaporizer may degrade to hydrogen fluoride, which c... Class I
Dec 11, 2023 Flow-i C40 Anesthesia System, model 6677400 Potential cybersecurity vulnerability that could lead to a Denial of Service ... Class II
Dec 11, 2023 Flow-i C30 Anesthesia System, model 6677300 Potential cybersecurity vulnerability that could lead to a Denial of Service ... Class II
Dec 11, 2023 Flow-e Anesthesia System, model 6887900 Potential cybersecurity vulnerability that could lead to a Denial of Service ... Class II
Dec 11, 2023 Flow-i C20 Anesthesia System, model 6677200 Potential cybersecurity vulnerability that could lead to a Denial of Service ... Class II
Dec 11, 2023 Flow-c Anesthesia System, model 6887700 Potential cybersecurity vulnerability that could lead to a Denial of Service ... Class II
Nov 8, 2023 Maquet Orchide OR Light Systems, Model Numbers and Catalog Numbers OHDII FHD ... A potential for a light system to fall in the operating room. Class II
Nov 8, 2023 Maquet Prismalix OR Light Systems, Model Numbers and Catalog Numbers 3001 - A... A potential for a light system to fall in the operating room. Class II
Nov 8, 2023 Maquet XTen OR Light Systems, Model Numbers and Catalog Numbers 3001 HMD14 - ... A potential for a light system to fall in the operating room. Class II
Nov 8, 2023 Maquet Hanaulux 2006/ 2007, Blue 100, Blue 130/ 90, Blue Series 30/ 80, and P... A potential for a light system to fall in the operating room. Class II
Nov 8, 2023 Maquet Hanaulux HLX2000 OR Light Systems, Model Numbers and Catalog Numbers 3... A potential for a light system to fall in the operating room. Class II
Nov 8, 2023 Maquet Axcel / Axcel + OR Light Systems, Model Numbers and Catalog Numbers AX... A potential for a light system to fall in the operating room. Class II
Nov 8, 2023 Maquet G8 / G8E OR Light Systems, Model Numbers and Catalog Numbers G8 LC E -... A potential for a light system to fall in the operating room. Class II
Nov 8, 2023 Maquet Hanaulux HLX3000 OR Light Systems, Model Numbers and Catalog Numbers H... A potential for a light system to fall in the operating room. Class II
Nov 8, 2023 Maquet Volista, Volista Access, Volista Access II, Volista Standop OR Light S... A potential for a light system to fall in the operating room. Class II
Nov 8, 2023 Maquet Equipment OR Light Systems, Model Numbers and Catalog Numbers BRAINLAB... A potential for a light system to fall in the operating room. Class II
Nov 8, 2023 Maquet PowerLEDII OR Light System, Model Names and Catalog Numbers PWDII77SF ... A potential for a light system to fall in the operating room. Class II
Nov 8, 2023 Maquet Lucea - Lucea10/40, Lucea50/100 OR Light Systems, Model Numbers and Ca... A potential for a light system to fall in the operating room. Class II
Nov 8, 2023 Maquet Rolite OR Light Systems, Model Numbers and Catalog Numbers ROL PWDII50... A potential for a light system to fall in the operating room. Class II
Nov 8, 2023 Maquet Blueline Series 30/80 OR Light Systems, Model Numbers and Catalog Numb... A potential for a light system to fall in the operating room. Class II
Nov 8, 2023 Maquet PowerLED/HLED and PowerLED300 OR Light Systems, Model Numbers and Cata... A potential for a light system to fall in the operating room. Class II
Sep 6, 2023 Meera Mobile Operating Table-to support and position the patient immediately ... Under certain conditions, an issue might prevent the device from performing a... Class II
Dec 22, 2022 Getinge Flow-i Anesthesia Systems Flow-i C20, Part no. 6677200 Flow-i C30, ... Due to a software bug, under certain conditions, pressure cannot be built up ... Class I
Dec 22, 2022 Getinge Flow-c Anesthesia System, Part No. 6887700 Due to a software bug, under certain conditions, pressure cannot be built up ... Class I
Dec 22, 2022 Getinge Flow-e Anesthesia System, Part No. 6887900 Due to a software bug, under certain conditions, pressure cannot be built up ... Class I
Nov 7, 2022 Flow-c Anesthesia System (Product Code 6887700) Flow-e Anesthesia System (Pr... The power backup battery, under certain conditions, may exhibit reduced batte... Class II
Oct 14, 2022 Extension Tabletop for Operating Table System 1140, Model Nos. 1140.20F0 and ... The back rest may unintentionally drop suddenly, resulting in adverse health ... Class II
Jul 21, 2022 Servo-air Ventilator System-The Servo-air Ventilator System is: Intended for ... Device does not meet regulatory requirements of stability while stationary, w... Class II
Jul 20, 2022 Maquet Critical Care AB/Getinge Servo-u Ventilator System, Part Number 6694... Ventilators may generate a combination of alarms which may result in loss of ... Class I
May 6, 2022 VOLISTA StandOP Surgical Light, Product Code/Part Numbers ARD568811901 VLT600... Paint particles may detach and fall in the operating field. In the worst case... Class II
May 2, 2022 Flow-e Anesthesia System : Intended for use in administering anesthesia while... Potential for crack to form on the on/off switch of the suction unit, which m... Class I
May 2, 2022 Flow-c Anesthesia System : intended for use in administering anesthesia whil... Potential for crack to form on the on/off switch of the suction unit, which m... Class I
Apr 13, 2022 Getinge CM320-2 CHAMBER WU Series Washer Disinfector- For Use as a multi-cham... Verification of installation not documented or may be incomplete, could resul... Class II
Apr 13, 2022 Getinge CM320 WUWD Series Washer Disinfector-For use as a multi-chamber washe... Verification of installation not documented or may be incomplete, could resul... Class II
Apr 1, 2022 Getinge 9100-Series Washer Disinfector models: 9120E, 9125E, 9127E, 9128E, 91... Inadequate documentation verifying whether device installation has been execu... Class II
Dec 9, 2021 Vaporizer Sevoflurane Maquet Filling, Part No. 6886601 Component of the fo... A potential chemical degradation of Sevoflurane by Lewis acids (metal oxides ... Class I

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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