Table, Surgical With Orthopedic Accessories, Ac-Powered
FDA product code JEA · Class I (low risk) · 21 CFR 878.4960 · General, Plastic Surgery
10510(k) clearances
0PMA approvals
41recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K953071 | Stryker COMMAND2 Office ConsoleJEA · Traditional | Stryker Instruments | 08/08/1995SE |
| K924094 | Mend ApcJEA · Traditional | Mend Technologies, Inc. | 03/30/1993SE |
| K910736 | Jackson Multipurpose Operating TableJEA · Traditional | Orthopedic Systems, Inc. | 05/21/1991SE |
| K911522 | Arthrobot(Tm) Wrist Holder AccessoryJEA · Traditional | Andronic Devices, Ltd. | 04/29/1991SE |
| K900290 | Skytron Model 1100 and Model 142JEA · Traditional | Skytron, Div. the Kmw Group, Inc. | 02/20/1990SE |
| K894789 | Dmi 250 Series Power Surgery TableJEA · Traditional | M.D. Intl., Inc. | 08/29/1989SE |
| K881060 | Osi Rizzoli Trauma Table (Electric Version)JEA · Traditional | Orthopedic Systems, Inc. | 03/25/1988SE |
| K874762 | Arthrotract Upper Limb Traction AccessoryJEA · Traditional | Andronic Devices, Ltd. | 12/10/1987SE |
| K873080 | Arthrobot 101 Upper Limb Traction AccessoryJEA · Traditional | Andronic Devices, Ltd. | 11/25/1987SE |
| K873079 | Arthrobot 100 Upper Limb PositionerJEA · Traditional | Andronic Devices, Ltd. | 11/25/1987SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1419-2025 Class II | Baxter TruSystem 7500 Hybrid Plus (FC), Product Code 1854087There 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-1418-2025 Class II | Baxter TruSystem 7500 Hybrid (SC), Product Code 1854086There 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-1417-2025 Class II | Baxter TruSystem 7500 Hybrid (FC), Product Code 1854085There 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-1412-2025 Class II | Baxter Mobile column TruSystem 7500, Product Code 1717023There 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-1411-2025 Class II | Baxter Floor mounting column TruSystem 7500, Product Code 1717021There 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-1410-2025 Class II | Baxter Stationary column TruSystem 7500, Product Code 1717020There 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-0218-2025 Class II | Baxter Operating Table TruSystem 7000 U14 (MBW) V, Product code REF 2065386The firm received customer reports stating that the batteries and their connectors experienced electrical… | Baxter Healthcare Corporation | 09/19/2024Open, Classified |
| Z-0217-2025 Class II | Baxter Operating Table TruSystem 7000 U14 (MBW), Product code REF 2065385The firm received customer reports stating that the batteries and their connectors experienced electrical… | Baxter Healthcare Corporation | 09/19/2024Open, Classified |
| Z-0216-2025 Class II | Baxter Operating Table TruSystem 7000 (dV) V, Product code REF 1841083The firm received customer reports stating that the batteries and their connectors experienced electrical… | Baxter Healthcare Corporation | 09/19/2024Open, Classified |
| Z-0215-2025 Class II | Baxter Operating Table TruSystem 7000 (MBW) V, Product code REF 1841082The firm received customer reports stating that the batteries and their connectors experienced electrical… | Baxter Healthcare Corporation | 09/19/2024Open, Classified |
| Z-0214-2025 Class II | Baxter Operating Table TruSystem 7000 V, Product code REF 1841050The firm received customer reports stating that the batteries and their connectors experienced electrical… | Baxter Healthcare Corporation | 09/19/2024Open, Classified |
| Z-0213-2025 Class II | Baxter Operating Table TruSystem 7000 (dV), Product code REF 1841049The firm received customer reports stating that the batteries and their connectors experienced electrical… | Baxter Healthcare Corporation | 09/19/2024Open, Classified |
| Z-0212-2025 Class II | Baxter Operating Table TruSystem 7000 (MBW), Product code REF 1841048The firm received customer reports stating that the batteries and their connectors experienced electrical… | Baxter Healthcare Corporation | 09/19/2024Open, Classified |
| Z-0211-2025 Class II | Baxter Operating Table TruSystem 7000, Product code REF 1841046The firm received customer reports stating that the batteries and their connectors experienced electrical… | Baxter Healthcare Corporation | 09/19/2024Open, Classified |
| Z-1149-2021 Class II | OT1000 Series Orthopedic Surgical TablesOn January 7, 2021, STERIS identified that the glued bond between the beam and the leg spar assembly may… | Steris Corporation | 01/21/2021Terminated |
| Z-0091-2021 Class II | Levo Arm Label: LEVO ARM REF 7887-050 MIZUHO OSI Refurbished Levo Arm Label: LEVO ARM…Due to the potential for fluid ingress into the Arm which could affect the device's electrical system and… | Mizuho OSI | 10/14/2019Terminated |
| Z-0391-2017 Class II | OR Table, Top U26 H V, Model # 1909793; OR Table Top U26 H V U, Model # 1909794; OR…Trumpf has identified six incidents of pinched cables. | Trumpf Medical Systems, Inc. | 10/25/2016Terminated |
| Z-0043-2017 Class II | Operating Table TruSystem 7000 U, Material Number 1604788; Operating Table TruSystgem…Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters. | Trumpf Medical Systems, Inc. | 07/10/2016Terminated |
| Z-0042-2017 Class II | Floor Mounting Column TS 7500 U, Material Number 1730732; Floor Mounting Column ARTIS…Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters. | Trumpf Medical Systems, Inc. | 07/10/2016Terminated |
| Z-0041-2017 Class II | Stationary Column TruSystem 7599, Material Number 1717020 Patient positioning during…Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters. | Trumpf Medical Systems, Inc. | 07/10/2016Terminated |
| Z-0040-2017 Class II | Mobile Column TruSystem 7500, Material Number 1717023; Mobile Column TruSystem 5500…Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters. | Trumpf Medical Systems, Inc. | 07/10/2016Terminated |
| Z-2248-2016 Class II | OT1000 Series Orthopedic Surgical TablesSTERIS has identified that the pivot pin assembly located on the table top may become loose preventing the… | Steris Corporation | 05/23/2016Terminated |
| Z-0759-2016 Class II | Patient transport Shuttle with Trendelenburg quick adjustment function (Jupiter, Mars…Complaints were received of the table top on the transporter (shuttle) tilting down quickly in a maximum… | Trumpf Medical Systems, Inc. | 01/19/2016Terminated |
| Z-0929-2015 Class II | IR remote control JUC, BUTTON, Material no.1239824, Serial number: to (incl.) 100139854.…Complaints have been reported of unintended movement occurring during surgical cases due to the use of… | Trumpf Medical Systems, Inc. | 12/03/2014Terminated |
| Z-0928-2015 Class II | Cable remote control JUC, BUTTON, Material no.1239823, Serial number: to (incl.)…Complaints have been reported of unintended movement occurring during surgical cases due to the use of… | Trumpf Medical Systems, Inc. | 12/03/2014Terminated |
| Z-0927-2015 Class II | IR remote control JUX, Material no.1307314, Serial number: to (incl.) 102338310 Patient…Complaints have been reported of unintended movement occurring during surgical cases due to the use of… | Trumpf Medical Systems, Inc. | 12/03/2014Terminated |
| Z-0926-2015 Class II | Cable remote control JUX Material, no.1307315, Serial number: to (incl.) 101287649.…Complaints have been reported of unintended movement occurring during surgical cases due to the use of… | Trumpf Medical Systems, Inc. | 12/03/2014Terminated |
| Z-0925-2015 Class II | (R)Cable remote control JUPITER, Material no.1219655, Serial number: to (incl.)…Complaints have been reported of unintended movement occurring during surgical cases due to the use of… | Trumpf Medical Systems, Inc. | 12/03/2014Terminated |
| Z-0924-2015 Class II | (R)IR remote control JUPITER, Material no.1219656, Serial number: to (incl.) 102317869.…Complaints have been reported of unintended movement occurring during surgical cases due to the use of… | Trumpf Medical Systems, Inc. | 12/03/2014Terminated |
| Z-0923-2015 Class II | IIR remote control JUPITER, Material no.4544120, Serial number: to (incl.) 102006720.…Complaints have been reported of unintended movement occurring during surgical cases due to the use of… | Trumpf Medical Systems, Inc. | 12/03/2014Terminated |
| Z-0922-2015 Class II | IR remote control JUPITER / TS7500, Material no.1601927, Serial number: to (incl.)…Complaints have been reported of unintended movement occurring during surgical cases due to the use of… | Trumpf Medical Systems, Inc. | 12/03/2014Terminated |
| Z-0921-2015 Class II | IR remote control JUPITER U, Material no. 4500120, Serial number: to (incl.) 102306940.…Complaints have been reported of unintended movement occurring during surgical cases due to the use of… | Trumpf Medical Systems, Inc. | 12/03/2014Terminated |
| Z-0920-2015 Class II | Cable remote control JUPITER, Material no. 4544119, Serial number: to (incl.) 102284378.…Complaints have been reported of unintended movement occurring during surgical cases due to the use of… | Trumpf Medical Systems, Inc. | 12/03/2014Terminated |
| Z-0919-2015 Class II | Cable remote control JUPITER / TS7500, Material no.1601926, Serial number: to (incl.)…Complaints have been reported of unintended movement occurring during surgical cases due to the use of… | Trumpf Medical Systems, Inc. | 12/03/2014Terminated |
| Z-0918-2015 Class II | Cable remote control JUPITER U, Material no.4500119, Serial number: to (incl.)…Complaints have been reported of unintended movement occurring during surgical cases due to the use of… | Trumpf Medical Systems, Inc. | 12/03/2014Terminated |
| Z-0141-2015 Class II | TITAN Operating Room Table Patient positioning during surgery, ranging from anesthesia…Unintended movement of the operating table during surgical cases due to the use of damaged TITAN remotes. | Trumpf Medical Systems, Inc. | 10/09/2014Terminated |
| Z-0155-2014 Class III | ORBIT PT. The ORBIT PT works in conjunction with an TRUMPF mobile operating table to…An odor and smoke developed - The cause was determined to be a power supply unit sitting in the controller… | Trumpf Medical Systems | 07/24/2013Terminated |
| Z-0810-2013 Class II | Mizuho Orthopedic Table, model 5855, sub assembly 5855-901 Orthopedic Table Spar.Possible instability of Orthopedic Table Top. If the epoxy bond fails, the aluminum plug may migrate out of… | Mizuho OSI | 12/17/2012Terminated |
| Z-0073-2012 | Mizuho OSI Modular Table System; Product Usage: For use in orthopaedic surgery to…Reports of injury related incidents while using the Mizuho OSI Modular Table System. | Mizuho Orthopedic Systems Inc | 07/29/2011Terminated |
| Z-0924-2011 | Mizuho ProFx 6850 Operating Room Table, with orthopedic accessories, AC Powered…Device component spar gear box locks up and may result in failure of push pull tube, which may result in… | Mizuho Orthopedic Systems Inc | 03/30/2010Terminated |
| Z-0242-2008 | OSI ProFx Operating Room Table 6850 , Pelvic Reconstruction Orthopedic Surgery Table--…Failure to anchor; due to a failure in the locking mechanism, the product may not anchor properly. | Mizuho Orthopedic Systems Inc | 02/28/2007Terminated |