TRUMPF Medizin Systeme GmbH + Co. KG P.O. box 24 44 07310 Saalfeld Germany TRUMPF Medizin Systeme GmbH + Co. KG Carl-Zeiss-Straße 7-9 07318 Saalfeld Telephone +49 3671 586 -0 Fax +49 3671 586 -41105 [email protected] www.trumpf-med.com Date 2015-12-21 FSCA Ref. No. Trumpf4 Urgent Field Safety Notice Corrective Action concerning Spring arms of Trumpf Medical Surgical Lighting, Camera and Monitor Systems Biennial Inspection of Welds Dear Customer, Within the framework of our product monitoring we consider it our responsibility to inform you of the risks to patients and users that can arise when using the following products: Product name Serial numbers iLED 3/5 TruLight 3000/5000 Helion/Xenion S/M/L all TruVidia SD TruVidia HD VidiaPort (Monitor brackets) Description of the problem: Trumpf Medical has been notified by its supplier that there is potential for fatigue fractures to develop in welds of spring arms over time when subject to extreme forces. Trumpf Medical does not have complaints related to this failure mode. The supplier has advised that a visual inspection of the welded joints should be completed on a bi-annual basis as advised in the User Manual since July 2010. This inspection should therefore be occurring for all Trumpf Medical Surgical light, camera and monitor arm system, spring arms. V100 www.trumpf-med.com TRUMPF Medizin Systeme GmbH + Co. KG, Sitz Saalfeld, Amtsgericht Jena HRA 502248 Unlimited Liability Partner:TRUMPF Medizin Systeme Beteiligungs-GmbH, Puchheim, Amtsgericht München HRB 139265 Managing Board: Simone Faath, Taylor Smith Actions to be taken: • If you are due for biennial maintenance then contact your authorized service partner to schedule your two-yearly preventative maintenance to include a visual inspection of the welds. Standard maintenance charges may apply. • If biennial maintenance is not yet due and your authorized partner did not inspect the welds on your previous inspection then contact them to schedule a service call to do the visual check of your welds. • Store the Supplement to the User Manual (Attachment 2) with your Trumpf User Manual(s) and ensure that the preventative maintenance requirements for this product are updated in any additional locations you may have stored them. • Complete and return the attached Confirmation of Receipt form (Attachment 1). Please note: your completed Confirmation of Receipt document demonstrates your compliance to updating all the necessary User Manuals within your facility. Passing along this information: Please make sure that, in your organization, all users of the devices listed above as well as any other personnel who must be informed, have been made aware of this safety information. If you have provided devices to third parties, please forward them a copy of this information, or inform the contact person listed above. Confirmation of receipt: Please confirm the receipt of this safety information by sending us the completed form in Attachment 1. The on-time return will stop you from receiving further letters on this issue. We require executing these measures to guarantee patient and user safety and we ask for your understanding. Contact person Trumpf Medical: TRUMPF Medizin Systeme GmbH + Co. KG Ms Julia Bielmeier Carl-Zeiss-Str. 7-9 D-07318 Saalfeld Telephone +49 3671 586 41 504 Fax +49 3671 586 41 487 [email protected] The appropriate Regulatory Agency has been notified of this Field Safety Corrective Action. Dr. Manfred Fehn Director of Quality Management Attachments: Attachment 1 Confirmation of Receipt Attachment 2 Supplement to the User Manual V100 www.trumpf-med.com TRUMPF Medizin Systeme GmbH + Co. KG, Sitz Saalfeld, Amtsgericht Jena HRA 502248 Unlimited Liability Partner:TRUMPF Medizin Systeme Beteiligungs-GmbH, Puchheim, Amtsgericht München HRB 139265 Managing Board: Simone Faath, Taylor Smith Appendix A – Spring Arm Material Numbers Mat. Nr. Description 0376288 Federarm 3kg, 3 polig (Swing) 0376289 Federarm 12-18kg, 5-polig Kamera eco 0376290 Federarm TFT Stop AC 2000, 9-15kg 0376291 Federarm TFT Stop AC 3000, 12-18kg 0376292 0376293 Federarm TFT Stop Space bis 30kg Federarm 3-polig NRH 0376294 Federarm 5-polig NRH 0376295 Federarm 3-polig NRH gerader Abgang 0376296 0379528 Federarm 5-polig NRH gerader Abgang FA AC3000, Stop 7-11KG 0385719 FA AC 2000 NRH mobil 3p, 12-18kg NG 1387323 Federarmsicherungssegment AC3000 1387324 1388338 Federarmsicherungssegment AC2000 Federarm 12-18 kg 3 polig, HEL2 1388339 Federarm 12-18 kg 5 polig HEL2 1388340 Federarm 12-18 kg 9 polig (HELION) 1408906 1471010 FA AC2 Stop max 11kg FA AC2000 3p, 12-18kg 1471011 FA AC2000 Stop 12-18kg 1471012 FA AC2000 NRH 3p, 12-18kg 1471013 1471014 1471015 1471016 1471017 1471018 1471351 1502084 1504731 1507085 1645860 1645861 1649687 1649872 1649997 1774143 1982310 1982311 1982312 1982313 4024211 FA AC2000, 7p, 12-18kg FA AC2000 NRH 7p, 12-18kg FA AC3000 3p, 23-30kg FA AC2000 Stop 6-11kg FA AC2000 TruVidia 7p, 3,5-7kg FA AC2000 Stop 3,5-7kg FA AC3000 NRH 3p, 23-30kg FA AC2 NRH für HEL2, 3POL. Federarm 9-POLIG NRH HEL2 (R)FEDERARM AC2000 FA AC 2000 NRH mobil 7p, 12-18kg NG FA AC 2000 NRH 7p, 12-18kg NG FA AC 2000 SlimLine STOP, 12-18kg FA AC 2000 SlimLine 3p, 12-18kg Deckenrohr 2f Slimline 1000 Ausleger AC2000, 750mm, 3p FA AC2000 MAVIG Protegra2 6-11kg FA AC2000 MAVIG Protegra2 12-18kg FA AC2000 3p, 13,5-21kg FA AC2000 NRH 3p, 13,5-21kg Federarm AC2000 V100 www.trumpf-med.com TRUMPF Medizin Systeme GmbH + Co. KG, Sitz Saalfeld, Amtsgericht Jena HRA 502248 Unlimited Liability Partner:TRUMPF Medizin Systeme Beteiligungs-GmbH, Puchheim, Amtsgericht München HRB 139265 Managing Board: Simone Faath, Taylor Smith 4024212 4024213 4024214 4024215 4024651 4024652 4024848 4025574 4025575 4025576 8800900 8800901 8800905 8800906 8800907 8800908 8800909 8800910 8800911 8800915 8800916 8800919 8800920 8800925 8800926 8800929 8800930 8801000 8801001 8801007 8801008 8801009 8801010 8801011 8801012 8801013 8801014 8801015 8801016 8801017 8801018 8801019 8801020 8801021 8801033 8801050 8801051 FA AC2 Stop FA AC3 FA AC3000 Stop, 12-18kg FA AC5000 Stop FA AC3000, 7p FA AC2 3K Federarm AC3000 NRH FA AC3000 Stop 23-30 kg FA AC5000 Stop max 15 kg FA AC2 K TruVidia Federarm HELION L+ 12,5 kg 5-polig Federarm HELION M+ 12,5 kg 3-polig Federarm HEL L/L+, 11,4 kg 3-polig Federarm HELION M NRH Federarm FA 77 V 11,4 kg 3 polig Federarm FA 77 V 6,8 kg 3 polig Federarm für L-Leuchte So-Version Federarm für M-Leuchte So-Version Federarm FA 77 V 13 kg 3 polig Federarm FA 77 N 11,4 kg 5 polig Federarm FA 77 N 6,8 kg 5 polig Federarm FA 77 N 13 kg 5 polig Federarm FA 77 N 8,9 kg 5 polig Federarm FA 77 N 11,4 kg 7 polig Federarm Helion M NRH 7-polig Federarm FA 77 N 13 kg 7 polig Federarm FA 77 N 8,9 kg 7 polig Federarm HELION M+ 8.3 kg 5-polig Federarm HELION M+ 8,3 kg 3-polig Federarm AC 2000, 9-15 kg O. Elektrik Federarm AC 2000, 7-12 kg 5 polig Federarm AC 2000, 12-18 kg 5 polig Federarm Acrobat 2000 12-18 kg Federarm Federarm AC 2000 7-15 kg 3 polig mit Federarm AC 2000, 9-15 kg 7 polig Federarm für Helion M Federarm AC 2000, 1-3,5 kg 7 polig Federarm AC2000 9-15 kg 5-polig Federarm HELION S Mobile Federarm AC 2000, 12-18 kg 3 polig Federarm AC 2000, 1-3,5 kg 3 polig Federarm AC 2000, 12-18 kg 7 polig Federarm AC 2000, 1-3,5KG, Adapt. Anschl Federarm Deckenanschluß HELS Federarm AC 3000, 12-18 kg ohne Elektr. Federarm SPACE 20-40 kg ohne Elektrik V100 www.trumpf-med.com TRUMPF Medizin Systeme GmbH + Co. KG, Sitz Saalfeld, Amtsgericht Jena HRA 502248 Unlimited Liability Partner:TRUMPF Medizin Systeme Beteiligungs-GmbH, Puchheim, Amtsgericht München HRB 139265 Managing Board: Simone Faath, Taylor Smith 8801101 8801102 8801103 8801104 8807200 8894025 1425487 1768718 0385246 4024790 1419354 0384021 0385247 1695239 1695224 1886331 1695225 Federarm SWING 2-3 kg 3 POL. 120 Volt Federarm SWING 2-3 kg 3 POL. 230 Volt Federarm für HELION S Federarm SWING 2-3 kg 3 polig Federarm 6.5kg für HELION M+ Mobile Federarm WA 77, 8,3 kg 3 polig FA AC2 STOP 3,5KG - MAX 7KG FA AC 77, NRH 3P FA AC2000 NRH 3P, 12-18KG FA AC3000 NRH 7P FA AC3000 STOP (17 -26KG) FA AC2000 NRH MOBIL 3P 12-18KG FA AC2000 NRH MOBIL 7P, 12-18KG ACHSE 1F WL 800, 3P + FA SWING ACHSE 1F ZA 800, 3P + FA SWING BEFESTIGUNGSSET FA AC 77/2000/SWING STATIV MOBIL TL1000, 3P + FA SWING V100 www.trumpf-med.com TRUMPF Medizin Systeme GmbH + Co. KG, Sitz Saalfeld, Amtsgericht Jena HRA 502248 Unlimited Liability Partner:TRUMPF Medizin Systeme Beteiligungs-GmbH, Puchheim, Amtsgericht München HRB 139265 Managing Board: Simone Faath, Taylor Smith
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