Table, Surgical With Orthopedic Accessories, Ac-powered
General, Plastic Surgery · 21 CFR 878.4960
Recent MDR events
632 adverse event reports on file
- MTS T-PinJul 28, 2026MalfunctionMizuho Orthopedic Systems, Inc.2921578-2026-00019
- MTS T-PinJul 28, 2026MalfunctionMizuho Orthopedic Systems, Inc.2921578-2026-00021
- WILSON PLUS RADIOLUCENT FRAME SPINEJul 13, 2026InjuryMizuho Orthopedic Systems, Inc.2921578-2026-00018
- OP-TISCH SATURN SELECT 3.02Jul 8, 2026MalfunctionBaxter Healthcare Corporation3007143268-2026-00036
- TRIOS, TABLE BASEJul 8, 2026MalfunctionMizuho Orthopedic Systems, Inc.2921578-2026-00017
- LEVO STANDARD PACKAGEJun 19, 2026InjuryMizuho Orthopedic Systems, Inc.2921578-2026-00016
- ASSEMBLY, LEG SPARJun 4, 2026MalfunctionMizuho Orthopedic Systems, Inc.2921578-2026-00014
- HEAD-POSITIONING ACCESSORIESJun 1, 2026MalfunctionBaxter Healthcare Corporation3007143268-2026-00032
- ADVANCED CONTROL I-BASE DC INTERNATIONALMay 29, 2026MalfunctionMizuho Orthopedic Systems, Inc.2921578-2026-00015
- TABLE, HANA, 110 VMay 5, 2026DeathMizuho Orthopedic Systems, Inc.2921578-2026-00011
Event type breakdown
Recalls
41 recall events for this product code
- Baxter Healthcare CorporationOpen, ClassifiedMar 21, 2025
Baxter Stationary column TruSystem 7500, Product Code 1717020
There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
Z-1410-2025 · View FDA record ↗ - Baxter Healthcare CorporationOpen, ClassifiedMar 21, 2025
Baxter Floor mounting column TruSystem 7500, Product Code 1717021
There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
Z-1411-2025 · View FDA record ↗ - Baxter Healthcare CorporationOpen, ClassifiedMar 21, 2025
Baxter Mobile column TruSystem 7500, Product Code 1717023
There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
Z-1412-2025 · View FDA record ↗ - Baxter Healthcare CorporationOpen, ClassifiedMar 21, 2025
Baxter TruSystem 7500 Hybrid (FC), Product Code 1854085
There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
Z-1417-2025 · View FDA record ↗ - Baxter Healthcare CorporationOpen, ClassifiedMar 21, 2025
Baxter TruSystem 7500 Hybrid (SC), Product Code 1854086
There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
Z-1418-2025 · View FDA record ↗ - Baxter Healthcare CorporationOpen, ClassifiedMar 21, 2025
Baxter TruSystem 7500 Hybrid Plus (FC), Product Code 1854087
There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
Z-1419-2025 · View FDA record ↗ - Baxter Healthcare CorporationOpen, ClassifiedOct 24, 2024
Baxter Operating Table TruSystem 7000, Product code REF 1841046
The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.
Z-0211-2025 · View FDA record ↗ - Baxter Healthcare CorporationOpen, ClassifiedOct 24, 2024
Baxter Operating Table TruSystem 7000 (MBW), Product code REF 1841048
The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.
Z-0212-2025 · View FDA record ↗ - Baxter Healthcare CorporationOpen, ClassifiedOct 24, 2024
Baxter Operating Table TruSystem 7000 (dV), Product code REF 1841049
The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.
Z-0213-2025 · View FDA record ↗ - Baxter Healthcare CorporationOpen, ClassifiedOct 24, 2024
Baxter Operating Table TruSystem 7000 V, Product code REF 1841050
The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.
Z-0214-2025 · View FDA record ↗
Registered firms
25 firms currently registered for this product code
United Orthopedic Corporation
Hsinchu, TW
Surgix Medical Llc
Spring, TX, US
Baxter Medical Systems (suzhou) Co. Ltd
Taicang City Jiangsu, CN
Kanghui Medical Technology (suzhou) Co.,ltd
Suzhou Jiangsu, CN
Black Forest Medical Gmbh
FREIBURG Baden-Wurttemberg, DE
Uoc Usa Inc.
Irvine, CA, US
Galaxy India
NEW DELHI, IN
Getinge Ab
POZNAN Wielkopolskie, PL
Maquet Gmbh
RASTATT Baden-Wurttemberg, DE
Baxter Medical Systems Gmbh + Co. Kg
SAALFELD Thuringia, DE
Mindray Ds Usa, Inc.
Mahwah, NJ, US
Jorg & Sohn Gmbh
Ahorn-Schorkendorf Bavaria, DE
Paras Surgico Factory
Delhi, IN
Nanjing Mindray Bio-medical Electronics Co., Ltd.
Nanjing Jiangsu, CN
United Orthopedic Corp.
Kaohsiung, TW
Steris Corporation
MONTGOMERY, AL, US
American Surgical Specialties Company
Nashville, TN, US
Mizuho Orthopedic Systems, Inc.
UNION CITY, CA, US
Hill-rom Company, Inc.
Ladson, SC, US
Dexta Corp.
NAPA, CA, US
Gabriel Scientific Ou
Parnu linn Parnumaa, EE
Tecnocirurgica Comercio De Materiais Medicos Cirurgicos E Hospitalares Ltda
Rio Claro Sao Paulo, BR
Brainlab Se
Munich Bavaria, DE
United Poly Engineering Pvt. Ltd.
NEW DELHI, IN
510(k) clearances
10 clearances for this product code
- Stryker InstrumentsAug 8, 1995
K953071 · STRYKER COMMAND2 OFFICE CONSOLE
- Mend Technologies, Inc.Mar 30, 1993
K924094 · MEND APC
- Orthopedic Systems, Inc.May 21, 1991
K910736 · JACKSON MULTIPURPOSE OPERATING TABLE
- Andronic Devices, Ltd.Apr 29, 1991
K911522 · ARTHROBOT(TM) WRIST HOLDER ACCESSORY
- Skytron, Div. the Kmw Group, Inc.Feb 20, 1990
K900290 · SKYTRON MODEL 1100 AND MODEL 142
- M.D. Intl., Inc.Aug 29, 1989
K894789 · DMI 250 SERIES POWER SURGERY TABLE
- Orthopedic Systems, Inc.Mar 25, 1988
K881060 · OSI RIZZOLI TRAUMA TABLE (ELECTRIC VERSION)
- Andronic Devices, Ltd.Dec 10, 1987
K874762 · ARTHROTRACT UPPER LIMB TRACTION ACCESSORY