SIEMENS. Healthineers ** Rie Sosa oa ohare) ‘To users of the ACUSON NX2, ACUSON NX? Elite, ACUSON NX3, and ACUSON NX Elite ultrasound ystems withthe following software versions "ACUSON NS AOUSON NOE a ACUSON NIG Eide ACUSON N22 Eide Varios vats Ato. yeaa Aton Vana Seemterie vvat00 vex ato vans. ‘VANOE AIOE “Setieare Version FResotwng the Following varos vvex00 aoc. vane teswe Dear Valued Customer: “This eter is to natty you fan issue on your ACUSON NX2, ACUSON NX2 Eite, ACUSON NXS. and [AGUSON Nixa Elte Urasound system When does this issue aise and whats the potential risk to heath? [Ax prof our ongoing quality natves niemal testing reveaie a stuston where under specifies imaging Ccondtons durng pulsed wave Dopsler. there sa possbily fr varsducers o exceed the acouste Ouut power (AOP) values cefinea in Track 3 f the FOA Gusdance for aust and Stat Information or Manutactrers Seeking Marketing Clearance of Diagoste Ultrasound Syetems and Traneducers andthe Output Display Standard IEC 60601-2-57, ‘The probabity of occurrence of hs issue s remote. Durng routine cnical use. input values o the calculations for acouste ouput power afe updated each tme tne user presses the UPDATE key fr rea-tme acqusiten. If the issue were wm ocur hee is an exttemely remote thelncod hese imaging conditons could resut a bum cor tssve damage trom caviaton, We nave no reports of inuries or adverse events du to his ssue, What stens cam the uses take to avoid potential risks associated with this issue? ‘To avoid a situation where incorrect acoustic olput power values are used during pulsed wave Dopeer always press the UPDATE key proto aoqurng a rea-tme (lve) pulsed wave Doppler spectrum. The Utrasound system updaies the acousic output power values tothe correct values afer each press of he hey.‘Observe te folowing instuctons provided fr acouse output power in Chapter 2 of your nsructons for Use ‘Acoustic Output — Mechanical and Thermal Indices WARMING: Urraicundprocecures should be used fr vats reons. or he shortest peed of ne, and at Be lowest mechoncaltheral noe seing necessary produce crscly acceptable mages. “The utrasound system incorporates an output splay of Mechanics ané Thermal indices to allow you to ontor and t lt the amount of ulraround energy fats anstered tothe patent Mote Fer systems dstbsted inthe Ute States of Amara, refer to the Mecca Utrasound Safty uvascund (Shicaten progam bochare produced by fe AUM tat shee win Sitar ayer Hom wil this issue be resolved? ‘A software update which wil address this issue i current being developed. When this software becomes ‘2valable, 2 Siemens Heaihinee’s custome service representative wil contact you te Schedule your system Update. you have any further questions, lee contac your Customer Care Centr We sincerely regret any inconvenianoe this conditon may cause in your daly operations Siocerty, Siemens Macieal Soutons USA Uivasound Business Ares