Table, Operating-Room, Electrical
FDA product code GDC · Class I (low risk) · 21 CFR 878.4960 · General, Plastic Surgery
18510(k) clearances
0PMA approvals
27recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K971390 | Quantum 3080SP Surgical TableGDC · Traditional | STERIS Corporation | 05/15/1997SE |
| K970807 | Mobile Operating Table 1132.01GDC · Traditional | Stierlen-Maquet AG | 03/14/1997SE |
| K964273 | Dura-Board ArmboardGDC · Traditional | Allen Medical Systems, Inc. | 01/08/1997SE |
| K940616 | Skytron Elite 3500 TableGDC · Traditional | Skytron, Div. the Kmw Group, Inc. | 06/13/1994SE |
| K934744 | Midmark Magnum General Surgical TableGDC · Traditional | Midmark Corp. | 03/28/1994SE |
| K914758 | Mdt/Shampaine Model 4900B Surgical TableGDC · Traditional | Mdt Corp., Inc. | 12/19/1991SE |
| K915393 | Mdt/Shampaine Model 4900E Surgical TableGDC · Traditional | Mdt Corp., Inc. | 12/17/1991SE |
| K883613 | Oper. Table for Percutan. Trans. Coronary Angio.GDC · Traditional | Stierlen-Maquet AG | 09/15/1988SE |
| K853720 | Mobile Operating Table for Orl MicrosurgeryGDC · Traditional | Carl Zeiss, Inc. | 10/18/1985SE |
| K853480 | Skytron Elite 6000 & 6001 Surgical TablesGDC · Traditional | Skytron, Div. the Kmw Group, Inc. | 09/12/1985SE |
| K853535 | Trauma TableGDC · Traditional | Xre Corp. | 09/11/1985SE |
| K851021 | Mayfield Table-ElectricGDC · Traditional | Ohio Medical Instrument Co., Inc. | 05/21/1985SE |
| K851830 | Skytron Elite 7000 Micro-Surgery TableGDC · Traditional | Skytron, Div. the Kmw Group, Inc. | 05/17/1985SE |
| K851829 | Skytron Elite 3100 Surgical TableGDC · Traditional | Skytron, Div. the Kmw Group, Inc. | 05/17/1985SE |
| K850168 | Stille Scandia Operating Tables RC 3000,1100GDC · Traditional | Stille-Werner (Usa), Inc. | 03/28/1985SE |
| K843134 | Mobile Operating Table Heidelbergs 1130GDC · Traditional | Stierlen-Maquet AG | 09/07/1984SE |
| K821749 | Amsco Endoscopy TableGDC · Traditional | American Sterilizer Co. | 07/09/1982SE |
| K821665 | Pedestal Examining TableGDC · Traditional | American Hamilton | 06/24/1982SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2638-2026 Class II | Adapter for Head Positioning, Model/Catalog Number: 1739994, when used in conjunction…The Adapter for Head Positioning accessory may become loose during patient positioning and unintentionally… | Baxter Healthcare Corporation | 04/21/2026Open, Classified |
| Z-1422-2025 Class II | Baxter TruSystem 7500, Product Code 4091000There is a software issue which causes the upper back section to not be operable/adjustable when the… | Baxter Healthcare Corporation | 02/25/2025Open, Classified |
| Z-1421-2025 Class II | Baxter TruSystem 7500 Hybrid MR IMRIS, Product Code 2067886There is a software issue which causes the upper back section to not be operable/adjustable when the… | Baxter Healthcare Corporation | 02/25/2025Open, Classified |
| Z-1409-2025 Class II | Baxter Operating table column TS7500 MOBIUS, Product Code 1704695There is a software issue which causes the upper back section to not be operable/adjustable when the… | Baxter Healthcare Corporation | 02/25/2025Open, Classified |
| Z-0210-2025 Class II | Baxter Operating table TruSystem 7000 U (MB), Product codes: a) REF 1604786; b) REF…The firm received customer reports stating that the batteries and their connectors experienced electrical… | Baxter Healthcare Corporation | 09/19/2024Open, Classified |
| Z-2512-2024 Class II | Baxter PST 500 U, Precision Surgical Table, Part number (product code) 4080300Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the PST 500 U Precision… | Baxter Healthcare Corporation | 06/28/2024Open, Classified |
| Z-2470-2023 Class II | GS70H Salus Surgical Table, Product Code 18-071-70When the control of the operating table was used in Bluetooth mode, the operating table continued moving… | Skytron, LLC | 08/01/2023Open, Classified |
| Z-2469-2023 Class II | GS70 Salus Surgical Table, Product Code 18-070-70When the control of the operating table was used in Bluetooth mode, the operating table continued moving… | Skytron, LLC | 08/01/2023Open, Classified |
| Z-2109-2023 Class II | Allen Advance Chest Support with PadPotential for the device to crack where the Chest Base Prone support attaches to the carbon fiber operating… | Baxter Healthcare Corporation | 05/18/2023Open, Classified |
| Z-0180-2023 Class II | Simple Clamp, US/EURO Rails, UPPER EXTREMITY DISTRACTION CMPT, REF F-40018, #800101. To…the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a… | Baxter Healthcare Corporation | 09/20/2022Open, Classified |
| Z-0179-2023 Class II | Allen Life Assist Beach Chair, BCSSP-BEACH CHAIR , REF A-91501, #104002. For use with…the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a… | Baxter Healthcare Corporation | 09/20/2022Open, Classified |
| Z-0178-2023 Class II | Beach Chair Clamp, BEACH CHAIR SHLDER POSITIONER CMPT, REF A-90013, #800104. Component…the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a… | Baxter Healthcare Corporation | 09/20/2022Open, Classified |
| Z-0177-2023 Class II | Allen Standard Starburst, Mayfield/Doro, STANDARD SPINE POSITIONERS CMPT, REF A-70710…the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a… | Baxter Healthcare Corporation | 09/20/2022Open, Classified |
| Z-0176-2023 Class II | C-Flex Polar Head Positnr-Device Only, SSP-NEUROSURGICAL HEADREST, REF A-70701, #103001,the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a… | Baxter Healthcare Corporation | 09/20/2022Open, Classified |
| Z-0175-2023 Class II | Allen Advance Table, RSP-ADVANCE TABLE: a) REF A-71100-US, #107003, b) A-71101-EU…the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a… | Baxter Healthcare Corporation | 09/20/2022Open, Classified |
| Z-1293-2021 Class II | Mizuho CE IPX4, mode MOT-5602BW, 100-240, 50-60Hz, 400VA, REF 18-140-20 containing hand…There is a potential that hand control units may cause the tabletop to slide in the opposite direction from… | Mizuho OSI | 02/08/2021Open, Classified |
| Z-0567-2021 Class II | Microsurgical Operating Room Tables;7300BX (18-351-70).Unintended tilting of the Tabletop MST 7300BX and incorrect operation due to infrared operating signal… | Mizuho America, Inc. | 09/11/2019Open, Classified |
| Z-0566-2021 Class II | Microsurgical Operating Room Tables;7300B (18-350-70);Unintended tilting of the Tabletop MST 7300BX and incorrect operation due to infrared operating signal… | Mizuho America, Inc. | 09/11/2019Open, Classified |
| Z-1844-2016 Class II | EZ Slide Battery/line powered hydraulic table with removable leg section and 21 top…The potential exists within the identified tables that incorrectly manufactured parts have been used in… | Skytron, Div. The KMW Group, Inc | 04/06/2016Terminated |
| Z-0792-2016 Class II | Mizuho OSI Trios, Table Base; Voltage: 100-240V ~ 50/60 Hz Amps: 5,0-5.0A; Model 7803…Table Bases may have been assembled incorrectly, missing a retaining ring from the head end assembly. Over… | Mizuho OSI | 12/14/2015Terminated |
| Z-0196-2015 Class II | The 5085 is a general surgical table with high patient weight capacity, extended width…The 5085 and 5085SRT stainless steel column shrouds may become damaged as a result of misalignment during… | Steris Corporation | 10/10/2014Terminated |
| Z-1488-2013 Class II | Hand Controls for Operon D750, D752, D760, D820 and D850 The hand controls are used to…The firm received complaints for unintended movements. | Berchtold Corp. | 03/12/2013Terminated |
| Z-2168-2013 Class II | OPERON D850 Surgical Table Product Usage: Surgical TableTable was not lowering. | Berchtold Corp. | 04/16/2012Terminated |
| Z-2426-2012 Class II | STERIS 5085 and 5085 SRT Surgical Tables, Product Usage: The 5085 is a general surgical…STERIS has learned from Customer feedback and field service experience that damage from external impact to… | Steris Corporation | 04/06/2012Terminated |
| Z-1597-2009 | ASC2000 Ambulatory Surgical Table. Model #MTS110003. The device is used to provide…Upon investigation, the firm determined that repetitive rubbing of the hydraulic hoses against the interior… | Steris Corp | 04/17/2009Terminated |
| Z-1123-2009 | Operon Electrical Operating Room Table. The device is used as an electrical operating…Difficulty in pressing the button needed to release a bed part resulted in an injury to a caregiver's finger… | Berchtold Corp. | 02/02/2009Terminated |
| Z-0554-2007 | Cmax Surgical Table, Model No. 2182625, Manufactured by STERIS Corporation, 2720 Gunter…A variation in suppliers welding processes, at the inner section of the hydraulic lift column, of the… | Steris Corporation | 02/06/2007Terminated |