Trumpf Medical Systems recalls
Trumpf Medical Systems appears in 31 official U.S. recall notices indexed by RecallRadar, most recently on 2018-03-07.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 31 |
|---|---|
| Published | 2012-09-12 to 2018-03-07 |
| By agency | FDA Device (31) |
| By classification | Class II (30), Class III (1) |
| By status | terminated (30), completed (1) |
| Distribution named in notices | AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MO, MS, NC, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TX, US, UT, VA, WA, WI, WY |
Recalls
- Camera System, Television, Surgical without audio Intended for transmission and documentation of surgical interventions for the purpose of…
FDA Device · Class II · 2018-03-07 · Trumpf Medical Systems
Reason: The radiated emission from the TruVidia" Wireless Receiver is above the normative accepted limits, in which the radiated emission may interact with other devices in the operating room and cause them not to function prop… - OR Table, Top U26 H V, Model # 1909793
FDA Device · Class II · 2016-11-16 · Trumpf Medical Systems
Reason: Trumpf has identified six incidents of pinched cables. - Stationary Column TruSystem 7599, Material Number 1717020 Patient positioning during surgery, ranging from anesthesia induction to actual s…
FDA Device · Class II · 2016-10-12 · Trumpf Medical Systems
Reason: Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters. - Mobile Column TruSystem 7500, Material Number 1717023
FDA Device · Class II · 2016-10-12 · Trumpf Medical Systems
Reason: Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters. - Operating Table TruSystem 7000 U, Material Number 1604788
FDA Device · Class II · 2016-10-12 · Trumpf Medical Systems
Reason: Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters. - Floor Mounting Column TS 7500 U, Material Number 1730732
FDA Device · Class II · 2016-10-12 · Trumpf Medical Systems
Reason: Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters. - Patient transport Shuttle with Trendelenburg quick adjustment function (Jupiter, Mars, Titan, TruSystem and Saturn operating table systems)
FDA Device · Class II · 2016-02-17 · Trumpf Medical Systems
Reason: Complaints were received of the table top on the transporter (shuttle) tilting down quickly in a maximum Trendelenburg position. - Ceiling Mounted Surgical Light System TruLight 3000/5000 and Ceiling Mounted Surgical Light System iLED3/iLED5
FDA Device · Class II · 2016-01-06 · Trumpf Medical Systems
Reason: The firm has received 15 complaints over ten years related to the connection of the spring arm to the top horizontal arm of the lighting system that while positioning the light head enabled the spring arm and light head… - Trumpf Ceiling Mounted Surgical Lighting Systems,Helion/Xenion S/M/L, User Manual #1441784
FDA Device · Class II · 2015-08-19 · Trumpf Medical Systems
Reason: Complaints received of the front joint of the spring arm AC 2000 could break at the interface to the monitor. - Trumpf Ceiling Mounted Surgical Lighting Systems,TruVidia HD, User Manual #1513140
FDA Device · Class II · 2015-08-19 · Trumpf Medical Systems
Reason: Complaints received of the front joint of the spring arm AC 2000 could break at the interface to the monitor. - Trumpf Ceiling Mounted Surgical Lighting Systems,TruLight 3000/5000, User Manual #1528403
FDA Device · Class II · 2015-08-19 · Trumpf Medical Systems
Reason: Complaints received of the front joint of the spring arm AC 2000 could break at the interface to the monitor. - Trumpf Ceiling Mounted Surgical Lighting Systems,iLED 3/5, User Manual #1558932
FDA Device · Class II · 2015-08-19 · Trumpf Medical Systems
Reason: Complaints received of the front joint of the spring arm AC 2000 could break at the interface to the monitor. - Trumpf Ceiling Mounted Surgical Lighting Systems,TruVidia SD, User Manual #1400191
FDA Device · Class II · 2015-08-19 · Trumpf Medical Systems
Reason: Complaints received of the front joint of the spring arm AC 2000 could break at the interface to the monitor. - Cable remote control JUX Material, no.1307315, Serial number: to (incl.) 101287649
FDA Device · Class II · 2015-01-14 · Trumpf Medical Systems
Reason: Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes - IR remote control JUPITER / TS7500, Material no.1601927, Serial number: to (incl.) 102222333
FDA Device · Class II · 2015-01-14 · Trumpf Medical Systems
Reason: Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes - Cable remote control JUPITER / TS7500, Material no.1601926, Serial number: to (incl.) 101465919
FDA Device · Class II · 2015-01-14 · Trumpf Medical Systems
Reason: Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes - Cable remote control JUPITER, Material no. 4544119, Serial number: to (incl.) 102284378
FDA Device · Class II · 2015-01-14 · Trumpf Medical Systems
Reason: Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes - (R)IR remote control JUPITER, Material no.1219656, Serial number: to (incl.) 102317869
FDA Device · Class II · 2015-01-14 · Trumpf Medical Systems
Reason: Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes - Cable remote control JUPITER U, Material no.4500119, Serial number: to (incl.) 102306915
FDA Device · Class II · 2015-01-14 · Trumpf Medical Systems
Reason: Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes - (R)Cable remote control JUPITER, Material no.1219655, Serial number: to (incl.) 101998119
FDA Device · Class II · 2015-01-14 · Trumpf Medical Systems
Reason: Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes - IIR remote control JUPITER, Material no.4544120, Serial number: to (incl.) 102006720
FDA Device · Class II · 2015-01-14 · Trumpf Medical Systems
Reason: Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes - IR remote control JUC, BUTTON, Material no.1239824, Serial number: to (incl.) 100139854
FDA Device · Class II · 2015-01-14 · Trumpf Medical Systems
Reason: Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes - IR remote control JUPITER U, Material no. 4500120, Serial number: to (incl.) 102306940
FDA Device · Class II · 2015-01-14 · Trumpf Medical Systems
Reason: Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes - Cable remote control JUC, BUTTON, Material no.1239823, Serial number: to (incl.) 100143048
FDA Device · Class II · 2015-01-14 · Trumpf Medical Systems
Reason: Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes - IR remote control JUX, Material no.1307314, Serial number: to (incl.) 102338310 Patient positioning during surgery, ranging from anesthesia…
FDA Device · Class II · 2015-01-14 · Trumpf Medical Systems
Reason: Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes - TITAN Operating Room Table Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthe…
FDA Device · Class II · 2014-11-05 · Trumpf Medical Systems
Reason: Unintended movement of the operating table during surgical cases due to the use of damaged TITAN remotes. - Helion S Exam Light or H300 The device is intended to locally illuminate an examination area of the patient's body with high intensity ligh…
FDA Device · Class II · 2013-12-18 · Trumpf Medical Systems
Reason: Possible fatigue failure of the plastic joint may occur after an average use of seven years. - TruSystem Surgical Table (TS7000) Leg Section One Part Light HU Use of the Leg Section One Part Light HU is permitted only with the TRUMP…
FDA Device · Class II · 2013-11-27 · Trumpf Medical Systems
Reason: The coupler point (hood) of the Leg Section One Part Light may become detached from the leg section frame. - ORBIT PT. The ORBIT PT works in conjunction with an TRUMPF mobile operating table to automate the patient transport process
FDA Device · Class III · 2013-11-13 · Trumpf Medical Systems
Reason: An odor and smoke developed - The cause was determined to be a power supply unit sitting in the controller column. - Helion and Xenion surgical lights, 501/01 series KLM lights
FDA Device · Class II · 2012-10-24 · Trumpf Medical Systems
Reason: Incidents regarding fractures of the front joint of the spring arm have been reported. - Acrobat 3000 (AC3000) Spring Arm as support arm for iLED operating lights, TRUMPF Medizinsysteme GmbH + Co KG 82178 Puchheim
FDA Device · Class II · 2012-09-12 · Trumpf Medical Systems
Reason: Cracks can arise on the welded seam on the rear joint.