Table, Examination, Medical, Powered
General, Plastic Surgery · 21 CFR 878.4960
Recent MDR events
80 adverse event reports on file
- MIDMARKNov 29, 2022MalfunctionMidmark Corporation1523530-2022-00002
- TILT TABLE 630May 7, 2021MalfunctionTri W-g Inc.11789613
- EXAM TABLEMar 20, 2020MalfunctionMidmark Corporation9859601
- STREAMLAB ANALYTICAL WORKCELLMar 17, 2020MalfunctionSiemens Healthcare Diagnostics Inc.2517506-2020-00104
- STREAMLAB ANALYTICAL WORKCELLJul 19, 2019MalfunctionSiemens Healthcare Diagnostics Inc.2517506-2019-00293
- BREWER ACCESS EXAM TABLENov 15, 2018InjuryThe Brewer Company, LlcMW5081405
- NEVADA ELECTRIC 4C 32X4.5 INCHES 110V SPA TABLEDec 4, 2017MalfunctionSilhouet Tone Corporation3005545844-2017-01605
- STREAMLAB® ANALYTICAL WORKCELLNov 3, 2017MalfunctionSiemens Healthcare Diagnostics Inc2517506-2017-00802
- RITTER 222Sep 11, 2017MalfunctionRitter / MidmarkMW5072070
- STREAMLAB® ANALYTICAL WORKCELLSep 8, 2017MalfunctionSiemens Healthcare Diagnostics Inc2517506-2017-00694
Event type breakdown
Recalls
15 recall events for this product code
- Oakworks IncOpen, ClassifiedJan 13, 2024
Ultrasound EA (Ergonomic Advantage) table versions; G2 (GENERAL 2) -An Ultrasound examination table
Backrest platform stress fracture - the table is not operational in an inclined position
Z-0727-2024 · View FDA record ↗ - Oakworks IncOpen, ClassifiedJan 13, 2024
Ultrasound EA (Ergonomic Advantage) table versions; G3 (General 3 Section) Echocardiography -An Ultrasound examination table
Backrest platform stress fracture - the table is not operational in an inclined position
Z-0728-2024 · View FDA record ↗ - Oakworks IncOpen, ClassifiedJan 13, 2024
Ultrasound EA (Ergonomic Advantage) table versions; G3 Multi-Specialty Echocardiography and Multi-Specialty with Electric Access Back Supports [left & right}
Backrest platform stress fracture - the table is not operational in an inclined position
Z-0729-2024 · View FDA record ↗ - Oakworks IncOpen, ClassifiedJan 13, 2024
Ultrasound EA (Ergonomic Advantage) table version; V2 (Vascular 2 Section) Echocardiography -An Ultrasound examination table
Backrest platform stress fracture - the table is not operational in an inclined position
Z-0730-2024 · View FDA record ↗ - Maquet Cardiovascular Us Sales, LlcTerminatedJun 4, 2019
GETINGE MEERA MOBILE OPERATING TABLE:
User may suffer an electric shock when coming in contact with the exposed electronic components
Z-1734-2019 · View FDA record ↗ - Medical Positioning IncTerminatedAug 13, 2014
Medical Positioning Rapid Response HUT table, Powered Medical Examination table, Model # 1017.
Excessive weight on the table will cause tables with the affected component to drop into the Trendelenburg position more rapidly than normal. The product was manufactured with a component that can cause the device to malfunction.
Z-2208-2014 · View FDA record ↗ - Medical Positioning IncTerminatedAug 13, 2014
Medical Positioning Rapid Response HUT table, Powered Medical Examination table, Model # 1019.
Excessive weight on the table will cause tables with the affected component to drop into the Trendelenburg position more rapidly than normal. The product was manufactured with a component that can cause the device to malfunction.
Z-2209-2014 · View FDA record ↗ - Medical Positioning IncTerminatedAug 13, 2014
Medical Positioning Rapid Response HUT table with Dual 2 Way Drop Section, Powered Medical Examination table, Model # 1217.
Excessive weight on the table will cause tables with the affected component to drop into the Trendelenburg position more rapidly than normal. The product was manufactured with a component that can cause the device to malfunction.
Z-2210-2014 · View FDA record ↗ - Medical Positioning IncTerminatedAug 13, 2014
Medical Positioning Rapid Response HUT table, Powered Medical Examination table, Model # 1219.
Excessive weight on the table will cause tables with the affected component to drop into the Trendelenburg position more rapidly than normal. The product was manufactured with a component that can cause the device to malfunction.
Z-2211-2014 · View FDA record ↗ - Maquet Cardiovascular Us Sales, LlcTerminatedJul 1, 2013
MAQUET Getinge Group Mobile Operating Table YUNO OTN GA 1433.01 EN 05.
MAQUET has identified a potential issue with the extension device handle (part number 1433.62A1) and will make enhancements to the YUNO table (part number 1433.01F0). Identification of the Extension device issue: By fully actuating the lever of the extension device handle, the operator's skin can enter a gap between the handle lever and a recess in the handle bar. When the lever is released,
Z-1622-2013 · View FDA record ↗
Registered firms
48 firms currently registered for this product code
Marketlab Incorporated
Caledonia, MI, US
Dexta Corp.
NAPA, CA, US
Hebei Jiede Medical Equipment Co., Ltd.
Hengshui Hebei, CN
Ningbo Ningyuan Import & Export Co., Ltd.
NINGBO, ZHEJIANG, CN
Olsen Industria E Comercio S/a
Palhoca Santa Catarina, BR
Reison Medical Ab
HALLSTAHAMMAR Vastmanland, SE
United Poly Engineering Pvt. Ltd.
NEW DELHI, IN
Shinyoung For M Co., Ltd.
Namyangju-si Gyeonggi, KR
Gokler Group
Sivas, TR
Umano Medical Inc.
Sherbrooke Quebec, CA
Akrus Gmbh & Co. Kg
Elmshorn Schleswig-Holstein, DE
Infinium Medical, Inc.
Largo, FL, US
Caretek(china) Medical Plc
Guangzhou City Guangdong, CN
Medical Positioning, Inc.
Lenexa, KS, US
Leander, Llc
Lawrence, KS, US
Jiangsu Sintang Health&technology Co.,ltd
Yancheng Jiangsu, CN
Stille Surgical Inc.
Lombard, IL, US
The Brewer Company Llc
MENOMONEE FALLS, WI, US
Pt. Mega Andalan Kalasan
JOGYAKARTA Yogyakarta, ID
Dre Med
Louisville, KY, US
Umano Medical Inc
L Islet Quebec, CA
Apex Health Care Mfg., Inc.
Min Hsiung Shiang Chiayi, TW
Heritage Medical Products, Inc
West Plains, MO, US
Stille Ab
Torshalla Sodermanland, SE
Silhouet-tone Usa
Miami, FL, US
510(k) clearances
14 clearances for this product code
- Tri W-G, Inc.Feb 17, 1995
K945163 · ECHOCARDIOGRAPHY
- Midmark Corp.Aug 28, 1989
K894134 · POWER EXAMINATION TABLE MODEL # 411
- Midmark Corp.Aug 28, 1989
K894144 · POWER EXAMINATION TABLE MODEL # 405
- Hamilton Industries, Inc.Oct 4, 1988
K883680 · MEDALIST EXAMINATION TABLE
- Enochs Mfg., Inc.Jul 13, 1988
K882010 · POWER EXAMINATION TABLE
- Cherne Industries, Inc.Nov 7, 1986
K864072 · ADEC 1005-C CHAIR
- F. & F. KoenigkramerFeb 19, 1986
K860519 · RELIANCE MODEL 200 PODIATRY CHAIR
- Storz Instrument Co.Jan 28, 1985
K845023 · STORZ PLASTIC SURGERY & EXAMINATION LOUNGE 7000