Reported Sep 7, 2022 · Ongoing
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific…
Boston Scientific Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 4100 Hamline Ave N · Saint Paul, MN · 55112-5700
Is this the product you have?
- The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
- Lot codes and dates
- UPN00802526434723
- Serial Numbers
1,742 of 1,742 codes
051026051075051091051121051146051156051171051182051207051232051236051239051270051320051335051358051367051370051374051413051418051425051432051435051456051459051473051478051486051487051495051501051511051533051535051549051552051558051561051580051584051592051593051612051623051626051632051640051655051696051727051745051763051769051770051784051808051818051846051850
- Serial Numbers
141 of 141 codes
051625051843054959055034055550055680055681055976056616056639056915056919057173057281057950058471058818058850058990059407060062060458060570062013062405062433062443062549063614064043064139064353065088066639066674066687066815066835066852066869066880066885066898066953066999067022067466067494067615067642067769068196068306068327068479068704068821068830068857069067
- Serial Numbers
178 of 178 codes
051130051136051571051610051628051639051644051756051772051890055100055118055177055218055244055301055334055370055482055506055511055540055839055922055939056418056478056527056853057025057097057448057674057747057810057842057930058079058096058197058234058336058521058827059036059231059349059536059881059992060135060488060815060888060929060935060981061999062210062296
- Serial Numbers
154 of 154 codes
051049051125051160051443051651051761052121052349054975055212055352055512055588055678055724055769055837055984056275056314056388056509056525056563056912056934057014057070057111057187057418057459057491057546057661057774057792057960057987058131058678058788058859058924058941058969059043059138059182059222059239059465059520059843059931059934059965060082060249060470
- Serial Numbers
87 of 87 codes
051361051608051749055029055114055194055489055642055847055903056028056067056142056181056241056362056397056789056882057844057926058373058395059020059241059290059301059616059935060198061859062097064167064220064825064843064848065032065107065472065565066638066799066847066943066947067014067451067578067651067828068213068258068303068315068316068484068532068663069053
- Serial Numbers
84 of 84 codes
051572051601051671051844051958055051055076055259055451055536055563055656055682055698055722055883055910056259056734056746056791056929056946056962057314057379057445058088058760058934060021060065060188060353060469060626060630062066062185062248062463063486063573064092064127064231064361064374064463064680064728064857065616065713065766066013066758066936067437067664
- Serial Numbers
166 of 166 codes
051424051509051804051815051928052015055153055159055232055315055401055475055998056016056326056343056361056375056475056488056606056613056854056955056982057034057051057076057178057185057275057324057545057652057772057804057851057865057870057943058142058325058352058523058555058732059015059294059378059387059488059551059595059633059634059641059785059838059884059954
- Serial Numbers
051616056600057919062305063553064509064522067524067758070864UPN 00802526478239
- Serial Numbers
106 of 106 codes
051214051888055183055291055624055807055892055926055980056201056495056504056626056684057023057127057182057213057354057424057593057715057751058012058207058235058255058277058507058829059050059056059297059298059399059690059856059871059909059996060221060610060772060825060893060976061062061900062166062323062324062451063709064140064165064327064644064751064772064891
- Serial Numbers
94 of 94 codes
051024051642051716052009055047055096055138055364055428055606055716055785056012056064056633056719056911057130057489057528057706057762057777057831058064058251058264058306058315058598058759059058059259059382059430059485059517059626059761060060060102060308060318060338060363060369060395060576060622062333064686064787065134065148065235065660065748065977065995066777
- Serial Numbers
267 of 267 codes
051101051334051401051461051591051622051723051762051811051822055064055141055144055234055303055339055483055490055518055582055614055628055705055979056042056047056079056285056396056443056750056767056880056932056973057045057086057198057506057554057628057761057830057935057959058153058287058361058384058386058405058543058635058683058686059021059053059152059173059292
- Serial Numbers
171 of 171 codes
074986074988074991074992074995075001075004075006075007075014075016075017075028075031075034075042075045075046075050075057075060075062075064075069075070075084075093075097075102075106075112075113075121075133075141075142075149075152075153075162075165075166075172075177075192075196075199075200075203075204075205075218075221075222075223075227075230075242075245075246
- Serial Numbers
466 of 466 codes
051057051105051247051394051441051603051872052185054955054976054989055014055195055222055290055294055314055322055340055379055410055418055508055604055612055688055740055803056001056043056097056189056203056226056265056429056505056517056564056587056637056714056735056803056881056992057003057015057028057083057125057171057244057387057423057788057846057880057899057901
- Serial Numbers
180 of 180 codes
051557051568051681051797055561055599055787056039056057056368056515056701056724056835056883057054057169057217057227057286057300057525057537057660057738057757058191058245058400058402058504058545058575058770058873059153059330059360059389059509059834059861059975060145060276060389060425060481060526060634060684060754060871060904061804061850061928061963061974062237
- Serial Numbers
171 of 171 codes
051100051139051579051726051742051776051902051957052037052439055102055201055221055435055491055528055549055584055767055801055830055884055921055933056000056066056129056166056202056305056323056491056682056849056874057013057030057148057193057262057383057516057586057746057766057806057965057992058326058410058444058458058522058721058971059044059197059254059279059308
- Amount recalled
- 17,172 units in total
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Why it was recalled
There is potential for unanticipated software anomalies to occur when using the Model 2868 Application loaded on the 3120 ZOOM LATITUTDE programmer when communicating with certain Boston Scientific transvenous defibrillators.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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