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Recall Observatory FDA recall evidence

Device product

A.T.S. 2200TS Tourniquet Systems, Personalized Pressure. Zimmer Surgical, Inc. Dover, OH 44622 Intended to be used by qualified professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities.

Z-0613-2018

July 27, 2017

Class II

Product summary

Firm
Zimmer Surgical Inc
Event
Event 78759
Status
Terminated
Classification
Class II
Quantity
8,231 devices total
Official record key
device-enforcement:Z-0613-2018

Official wording

Reason: Updated on-device label and 3 pages of an updated Operator/Service Manual. Also, decrease from 3.8 meters (m) to 1.0 separation distance between the device and RF communication equipment.

Code information: Lot No. Item No. 60400040400, Lot No. 62510548 (Serial Numbers: 2213JAAA, 2213JAAB, 2213JAAC, 2213JAAD, 2213JAAE, 2213JAAF, 2213JAAG, 2213JAAH, 2213JAAJ, 2213JAAK, 2213JAAL, 2213JAAM, 2213JAAN, 2213JAAP, 2213JAAQ, 2213JAAR, 2213JAAS, 2213JAAT, 2213JAAU, 2213JAAW, 2213JABA, 2213JABB, 2213JABC, 2213JABD, 2213JABE, 2213JABF, 2213JABG, 2213JABH); Lot No. 62534445 (Serial Numbers: 2213JABJ, 2213JABK, 2213JABL, 2213JABM, 2213JABN, 2213JABP, 2213JABQ, 2213JABR, 2213JABS, 2213JABT, 2213JABU, 2213JABW, 2213JACA, 2213JACB, 2213JACC, 2213JACD, 2213JACE, 2213JACF, 2213JACG, 2213JACH); Lot No. 62631977 (Serial Numbers: 2214BAAA, 2214BAAB, 2214BAAC, 2214BAAD, 2214BAAE, 2214BAAF, 2214BAAG, 2214BAAH, 2214BAAJ, 2214BAAK, 2214BAAL, 2214BAAM, 2214BAAN, 2214BAAP, 2214BAAQ, 2214BAAR, 2214BAAS, 2214BAAT, 2214BAAU, 2214BAAW); Lot No. 62625059 (Serial Numbers: 2214BABA, 2214BABB, 2214BABC, 2214BABD, 2214BABE, 2214BABF, 2214BABG, 2214BABH, 2214BABJ, 2214BABK, 2214BABL, 2214BABM, 2214BABN, 2214BABP, 2214BABQ, 2214BABR, 2214BABS, 2214BABT, 2214BABU, 2214BABW); Lot No. 62635789 (Serial Numbers: 2214CAAA, 2214CAAB, 2214CAAC, 2214CAAD, 2214CAAE, 2214CAAF, 2214CAAG, 2214CAAH, 2214CAAJ, 2214CAAK, 2214CAAL, 2214CAAM, 2214CAAV, 2214CAAP, 2214CAAQ, 2214CAAR, 2214CAAS, 2214CAAT, 2214CAAU, 2214CAAW); Lot No. 62642067 (Serial Numbers: 2214DAAA, 2214DAAB, 2214DAAC, 2214DAAD, 2214DAAE, 2214DAAF, 2214DAAG, 2214DAAH, 2214DAAJ, 2214DAAK, 2214DAAL, 2214DAAM, 2214DAAN, 2214DAAP, 2214DAAQ, 2214DAAR, 2214DAAS, 2214DAAT, 2214DAAU, 2214DAAW); Lot No. 62642068 (Serial Numbers: 2214EAAA, 2214EAAB, 2214EAAC, 2214EAAD, 2014EAAE, 2214EAAF, 2214EAAG, 2214EAAH, 2214EAAJ, 2214EAAK, 2214EAAL, 2214EAAM, 2214EAAN, 2214EAAP, 2214EAAQ, 2214EAAR, 2214EAAS, 2214EAAT, 2214EAAU, 2214EAAW); Lot No. 62675190 (Serial Numbers: 2214DABA); Lot No. 62732714 (Serial Numbers: 2214FAAA, 2214FAAB, 2214FAAC, 2214FAAD); Lot No. 62727347 (Serial Numbers: 2214FAAE, 2214FAAF, 2214FAAG, 2214FAAH); Lot No. 62727348 (Serial Numbers: 2214FAAJ, 2214FAAK, 2214FAAL); Lot No. 62745916 (Serial Numbers: 2214FAAM, 2214FAAN); Lot No. 62723747 (Serial Numbers: 2214FAAP, 2214FAAQ, 2214FAAR, 2214FAAS, 2214FAAT, 2214FAAU, 2214FAAW, 2214FABA, 2214FABB, 2214FABC, 2214FABD, 2214FABE, 2214FABF, 2214FABG, 2214FABH, 2214FABJ, 2214FABK, 2214FABL, 2214FABM, 2214FABN); Lot No. 62723748 (Serial Numbers: 2214FABP, 2214FABQ, 2214FABR, 2214FABS, 2214FABT, 2214FABU, 2214FABW, 2214FACA, 2214FACB, 2214FACC, 2214FACD, 2214FACE, 2214FACF, 2214FACG, 2214FACH, 2214FACJ, 2214FACK, 2214FACL, 2214FACM, 2214FACN); Lot No. 62758708 (Serial Numbers: 2214GAAA, 2214GAAB, 2214GAAC, 2214GAAD); Lot No. 62758711 (Serial Numbers: 2214GAAE); Lot No. 62760907 (Serial Numbers: 2214GAAF, 2214GAAG); Lot No. 63773338 (Serial Numbers: 2214GAAH, 2214GAAJ, 2214GAAK, 2214GAAL); Lot No. 62773820 (Serial Numbers: 2214GAAM, 2214GAAN); Lot No. 62773463 (Serial Numbers: 2214GAAP); Lot No. 62773471 (Serial Numbers: 2214GAAQ, 2214GAAR, 2214GAAS); Lot No. 62773478 (Serial Numbers: 2214GAAT, 2214GAAU, 2214GAAW, 2214GABA); Lot No. 62773485 (Serial Numbers: 2214GABB, 2214GABC); Lot No. 62748403 (Serial Numbers: 2214GABD, 2214GABE, 2214GABF, 2214GABG, 2214GABH, 2214GABJ, 2214GABK, 2214GABL, 2214GABM, 2214GABN, 2214GABP, 2214GABQ, 2214GABR, 2214GABS, 2214GABT, 2214GABU, 2214GABW, 2214GACA, 2214GACB, 2214GACC); Lot No. 62779664 (Serial Numbers: 2214GACD, 2214GACE); Lot No. 62797832 (Serial Numbers: 2214HAAA, 2214HAAB, 2214HAAC); Lot No. 62797833 (Serial Numbers: 2214HAAD, 2214HAAE, 2214HAAF, 2214HAAG, 2214HAAH); Lot No. 62799449 (Serial Numbers: 2214HAAJ, 2214HAAK, 2214HAAL, 2214HAAM, 2214HAAN, 2214HAAP, 2214HAAQ, 2214HAAR, 2214HAAS, 2214HAAT, 2214HAAU, 2214HAAW, 2214HABA, 2214HABB, 2214HABC, 2214HABD, 2214HABE, 2214HABF, 2214HABG, 2214HABH); Lot No. 62799475 (Serial Numbers: 2214HABJ, 2214HABK, 2214HABL, 2214HABM, 2214HABN, 2214HABP, 2214HABQ, 2214HABR, 2214HABS, 2214HABT, 2214HABU, 2214HABW, 2214HACA, 2214HACB, 2214HACC, 2214HACD, 2214HACE, 2214HACF, 2214HACG, 2214HACH); Lot No. 62824836 (Serial Numbers: 2214IAAA, 2214IAAB, 2214IAAC, 2214IAAD); Lot No. 62838042 (Serial Numbers: 2214IAAE, 2214IAAF, 2214IAAG, 2214IAAH); Lot No. 62812885 (Serial Numbers: 2214IAAJ, 2214IAAK, 2214IAAL, 2214IAAM, 2214IAAN, 2214IAAP, 2214IAAQ, 2214IAAR, 2214IAAS, 2214IAAT, 2214IAAU, 2214IAAW, 2214IABA, 2214IABB, 2214IABC, 2214IABD, 2214IABE, 2214IABF, 2214IABG, 2214IABH); Lot No. 62812853 (Serial Numbers: 2214IABJ, 2214IABK, 2214IABL, 2214IABM, 2214IABN, 2214IABP, 2214IABQ, 2214IABR, 2214IABS, 2214IABT, 2214IABU, 2214IABW, 2214IACA, 2214IACB, 2214IACC, 2214IACD, 2214IACE, 2214IACF, 2214IACG, 2214IACH); Lot No. 62846159 (Serial Numbers: 2214JAAA, 2214JAAB, 2214JAAC); Lot No. 62844916 (Serial Numbers: 2214JAAD); Lot No. 62869981 (Serial Numbers: 2214KAAE, 2214KAAF, 2214KAAG, 2214KAAH, 2214KAAJ); Lot No. 62871639 (Serial Numbers: 2214JAAE, 2214JAAF, 2214JAAG, 2214JAAH); Lot No. 62870928 (Serial Numbers: 2214KAAK, 2214KAAL, 2214KAAM, 2214KAAN, 2214KAAP, 2214KAAQ, 2214KAAR, 2214KAAS, 2214KAAT, 2214KAAU, 2214KAAW, 2214KABA, 2214KABB, 2214KABC, 2214KABD, 2214KABE, 2214KABF, 2214KABG, 2214KABH, 2214KABJ); Lot No. 62877932 (Serial Numbers: 221411110001, 221411110002, 221411110003, 221411110004, 221411110005, 221411110006, 221411110007, 221411110008, 221411110009, 221411110010); Lot No. 62885586 (Serial Numbers: 221411120001, 221411120002, 221411120003, 221411120004, 221411120005); Lot No. 62885587 (Serial Numbers: 221411120006, 221411120007, 221411120008, 221411120009, 221411120010, 221411120011, 221411120012, 221411120013, 221411120014, 221411120015); Lot No. 62895898 (Serial Numbers: 221411200001, 221411200002, 221411200003, 221411200004, 221411200005, 221411200006, 221411200007, 221411200008, 221411200009, 221411200010); Lot No. 62905257 (Serial Numbers: 221411240001); Lot No. 62904091 (Serial Numbers: 221411250001, 221411250002, 221411250003, 221411250004, 221411250005, 221411250006, 221411250007, 221411250008, 221411250009, 221411250010, 221411250011, 221411250012, 221411250013, 221411250014, 221411250015, 221411250016, 221411250017, 221411250018, 221411250019, 221411250020); Lot No. 62904093 (Serial Numbers: 221412010001, 221412010002, 221412010003, 221412010004, 221412010005, 221412010006, 221412010007, 221412010008, 221412010009, 221412010010, 221412010011, 221412010012, 221412010013, 221412010014, 221412010015, 221412010016, 221412010017, 221412010018, 221412010019, 221412010020); Lot No. 62879139 (Serial Numbers: 221412040001, 221412040002, 221412040003, 221412040004, 221412040005); Lot No. 62905838 (Serial Numbers: 221412080001, 221412080002, 221412080003, 221412080004, 221412080005); Lot No. 62895896 (Serial Numbers: 221412120001, 221412120002, 221412120003, 221412120004, 221412120005); Lot No. 62904123 (Serial Numbers: 221412150001, 221412150002, 221412150003, 221412150004, 221412150005, 221412150006, 221412150007, 221412150008, 221412150009, 221412150010, 221412150011, 221412150012, 221412150013, 221412150014, 221412150015, 221412150016, 221412150017, 221412150018, 221412150019, 221412150020); Lot No. 62932244 (Serial Numbers: 221412180001, 221412180002, 221412180003, 221412180004, 221412180005, 221412180006, 221412180007, 221412180008, 221412180009, 221412180010, 221412180011, 221412180012, 221412180013, 221412180014, 221412180015, 221412180016, 221412180017, 221412180018, 221412180019, 221412180020); Lot No. 62935217 (Serial Numbers: 221412190001, 221412190002, 221412190003, 221412190004, 221412190005); Lot No. 62937693 (Serial Numbers: 221501050001, 221501050002, 221501050003, 221501050004, 221501050005); Lot No. 62945082 (Serial Numbers: 221501080001, 221501080002, 221501080003, 221501080004, 221501080005); Lot No. 62945086 (Serial Numbers: 201501080006, 201501080007, 201501080008); Lot No. 62932650 (Serial Numbers: 221503090001, 221503090002, 221503090003, 221503090004, 221503090005, 221503090006, 221503090007, 221503090008, 221503090009, 221503090010, 221503090011, 221503090012, 221503090013, 221503090014, 221503090015, 221503090016, 221503090017, 221503090018, 221503090019, 22150309002); Lot No. 62961804 (Serial Numbers: 221503120001, 221503120002, 221503120003, 221503120004, 221503120005, 221503120006, 221503120007, 221503120008, 221503120009, 221503120010, 221503120011, 221503120012, 221503120013, 221503120014, 221503120015, 221503120016, 221503120017, 221503120018, 221503120019, 221503120020); Lot No. 62976480 (Serial Numbers: 221503190001, 221503190002, 221503190003, 221503190004, 221503190005, 221503190006, 221503190007, 221503190008, 221503190009, 221503190010, 221503190011, 221503190012, 221503190013, 221503190014, 221503190015, 221503190016, 221503190017, 221503190018, 221503190019, 221503190020); Lot No. 62976481 (Serial Numbers: 221503250001, 221503250002, 221503250003, 221503250004, 221503250005, 221503250006, 221503250007, 221503250008, 221503250009, 221503250010, 221503250011, 221503250012, 221503250013, 221503250014, 221503250015, 221503250016, 221503250017, 221503250018, 221503250019, 221503250020); Lot No. 63026460 (Serial Numbers: 221503270001, 221503270002, 221503270003, 221503270004, 221503270005); Lot No. 63007852 (Serial Numbers: 221504080001, 221504080002, 221504080003, 221504080004, 221504080005, 221504080006, 221504080007, 221504080008, 221504080009, 221504080010, 221504080011, 221504080012, 221504080013, 221504080014, 221504080015, 221504080016, 221504080017, 221504080018, 221504080019, 221504080020 Lot No. 63042181 (Serial Numbers: 221504140001, 221504140002, 221504140003, 221504140004, 221504140005); Lot No. 63042182 (Serial Numbers: 221504140006, 221504140007, 221504140008, 221504140009, 221504140010); Lot No. 63007853 (Serial Numbers: 221504140011, 221504140012, 221504140013, 221504140014, 221504140015, 221504140016, 221504140017, 221504140018, 221504140019, 221504140020, 221504140021, 221504140022, 221504140023, 221504140024, 221504140025, 221504140026, 221504140027, 221504140028, 221504140029, 221504140030); Lot No. 63042179 (Serial Numbers: 221504160001, 221504160002, 221504160003); Lot No. 63042184 (Serial Numbers: 221504220001, 221504220002, 221504220003, 221504220004, 221504220005); Lot No. 63037252 (Serial Numbers: 221504250001, 221504250002, 221504250003, 221504250004, 221504250005, 221504250006, 221504250007, 221504250008, 221504250009, 221504250010, 221504250011, 221504250012, 221504250013, 221504250014, 221504250015, 221504250016, 221504250017, 221504250018, 221504250019, 221504250020); Lot No. 63042180 (Serial Numbers: 221504280001, 221504280002, 221504280003, 221504280004, 221504280005, 221504280006, 221504280007, 221504280008, 221504280009, 221504280010, 221504280011, 221504280012, 221504280013, 221504280014, 221504280015, 221504280016, 221504280017, 221504280018, 221504280019, 221504280020); Lot No. 63042183 (Serial Numbers: 221505110001, 221505110002, 221505110003, 221505110004, 221505110005); Lot No. 63037254 (Serial Numbers: 221505120001, 221505120002, 221505120003, 221505120004, 221505120005, 221505120006, 221505120007, 221505120008, 221505120009, 221505120010, 221505120011, 221505120012, 221505120013, 221505120014, 221505120015, 221505120016, 221505120017, 221505120018, 221505120019, 221505120020); Lot No. 63092209 (Serial Numbers: 221506030001, 221506030002, 221506030003); Lot No. 63092210 (Serial Numbers: 221506050001, 221506050002, 221506050003, 221506050004, 221506050005); Lot No. 63072301 (Serial Numbers: 221506100001, 221506100002, 221506100003, 221506100004, 221506100005, 221506100006, 221506100007, 221506100008, 221506100009, 221506100010, 221506100011, 221506100012, 221506100013, 221506100014, 221506100015, 221506100016, 221506100017, 221506100018, 221506100019, 221506100020); Lot No. 63103587 (Serial Numbers: 221506130001, 221506130002, 221506130003, 221506130004, 221506130005, 221506130006, 221506130007, 221506130008, 221506130009, 221506130010, 221506130011, 221506130012, 221506130013, 221506130014, 221506130015); Lot No. 63072324 (Serial Numbers: 221506170001, 221506170002, 221506170003, 221506170004, 221506170005, 221506170006, 221506170007, 221506170008, 221506170009, 221506170010, 221506170011, 221506170012, 221506170013, 221506170014, 221506170015, 221506170016, 221506170017, 221506170018, 221506170019, 221506170020); Lot No. 63103164 (Serial Numbers: 221506170021, 221506170022, 221506170023); Lot No. 63072352 (Serial Numbers: 221506200001, 221506200002, 221506200003, 221506200004, 221506200005, 221506200006, 221506200007, 221506200008, 221506200009, 221506200010, 221506200011, 221506200012, 221506200013, 221506200014, 221506200015, 221506200016, 221506200017, 221506200018, 221506200019, 221506200020); Lot No. 63096468 (Serial Numbers: 221507150001, 221507150002, 221507150003, 221507150004, 221507150005, 221507150006, 221507150007, 221507150008, 221507150009, 221507150010, 221507150011, 221507150012, 221507150013, 221507150014, 221507150015, 221507150016, 221507150017, 221507150018, 221507150019, 221507150020); Lot No. 63109655 (Serial Numbers: 221507160001, 221507160002, 221507160003); Lot No. 63103590 (Serial Numbers: 221507210001, 221507210002, 221507210003, 221507210004, 221507210005, 221507210006, 221507210007, 221507210008, 221507210009, 221507210010, 221507210011, 221507210012, 221507210013, 221507210014, 221507210015); Lot No. 63109651 (Serial Numbers: 221507280001, 221507280002, 221507280003, 221507280004, 221507280005, 221507280006, 221507280007, 221507280008, 221507280009, 221507280010); Lot No. 63116357 (Serial Numbers: 221507290001, 221507290002, 221507290003, 221507290004, 221507290005, 221507290006, 221507290007, 221507290008, 221507290009, 221507290010, 221507290011, 221507290012, 221507290013, 221507290014, 221507290015, 221507290016, 221507290017, 221507290018, 221507290019, 221507290020); Lot No. 63123305 (Serial Numbers: 221508040001, 221508040002, 221508040003, 221508040004, 221508040005, 221508040006, 221508040007, 221508040008, 221508040009, 221508040010, 221508040011, 221508040012, 221508040013, 221508040014, 221508040015, 221508040016, 221508040017, 221508040018, 221508040019, 221508040020); Lot No. 63138553 (Serial Numbers: 221508260001, 221508260002, 221508260003, 221508260004, 221508260005, 221508260006, 221508260007, 221508260008, 221508260009, 221508260010, 221508260011, 221508260012, 221508260013, 221508260014, 221508260015, 221508260016, 221508260017, 221508260018, 221508260019, 221508260020); Lot No. 63138631 (Serial Numbers: 221509090001, 221509090002, 221509090003, 221509090004, 221509090005, 221509090006, 221509090007, 221509090008, 221509090009, 221509090010, 221509090011, 221509090012, 221509090013, 221509090014, 221509090015, 221509090016, 221509090017, 221509090018, 221509090019, 221509090020); Lot No. 63171089 (Serial Numbers: 221509240001, 221509240002, 221509240003, 221509240004, 221509240005, 221509240006, 221509240007, 221509240008, 221509240009, 221509240010, 221509240011, 221509240012, 221509240013, 221509240014, 221509240015, 221509240016, 221509240017, 221509240018, 221509240019, 221509240020); Lot No. 63202480 (Serial Numbers: 221510120001, 221510120002, 221510120003, 221510120004, 221510120005); Lot No. 63202478 (Serial Numbers: 221510220001, 221510220002, 221510220003, 221510220004, 221510220005, 221510220006, 221510220007, 221510220008, 221510220009, 221510220010, 221510220011, 221510220012, 221510220013, 221510220014, 221510220015, 221510220016, 221510220017, 221510220018, 221510220019, 221510220020); Lot No. 63234563 (Serial Numbers: 221511230001, 221511230002, 221511230003, 221511230004, 221511230005); Lot No. 63234565 (Serial Numbers: 221512020001, 221512020002, 221512020003, 221512020004, 221512020005); Lot No. 63212407 (Serial Numbers: 221512070001, 221512070002, 221512070003, 221512070004, 221512070005, 221512070006, 221512070007, 221512070008, 221512070009, 221512070010, 221512070011, 221512070012, 221512070013, 221512070014, 221512070015, 221512070016, 221512070017, 221512070018, 221512070019, 221512070020); Lot No. 63245752 (Serial Numbers: 221512160001, 221512160002, 221512160003, 221512160004, 221512160005, 221512160006, 221512160007); Lot No. 63253256 (Serial Numbers: 221512180001, 221512180002, 221512180003, 221512180004, 221512180005); Lot No. 63247425 (Serial Numbers: 221601060001, 221601060002, 221601060003, 221601060004, 221601060005, 221601060006, 221601060007, 221601060008, 221601060009, 221601060010, 221601060011, 221601060012, 221601060013, 221601060014, 221601060015, 221601060016, 221601060017, 221601060018, 221601060019, 221601060020); Lot No. 63526287 (Serial Numbers: 221612140001, 221612140002, 221612140003, 221612140004, 221612140005, 221612140006, 221612140007, 221612140008, 221612140009, 221612140010, 221612140011, 221612140012, 221612140013, 221612140014, 221612140015, 221612140016, 221612140017, 221612140018, 221612140019, 221612140020); Lot No. 63531691 (Serial Numbers: 221612150001, 221612150002, 221612150003, 221612150004, 221612150005, 221612150006, 221612150007); Lot No. 63526321 (Serial Numbers: 221612170001, 221612170002, 221612170003, 221612170004, 221612170005, 221612170006, 221612170007, 221612170008, 221612170009, 221612170010, 221612170011, 221612170012, 221612170013, 221612170014, 221612170015, 221612170016, 221612170017, 221612170018, 221612170019, 221612170020); Lot No. 63261584 (Serial Numbers: 221601070001, 221601070002, 221601070003, 221601070004, 221601070005); Lot No. 63264374 (Serial Numbers: 221601110001, 221601110002, 221601110003, 221601110004, 221601110005, 221601110006, 221601110007, 221601110008, 221601110009, 221601110010, 221601110011, 221601110012, 221601110013, 221601110014, 221601110015, 221601110016, 221601110017, 221601110018, 221601110019, 221601110020); Lot No. 63265280 (Serial Numbers: 221601140001, 221601140002, 221601140003, 221601140004, 221601140005, 221601140006, 221601140007); Lot No. 63257987 (Serial Numbers: 221601180001, 221601180002, 221601180003, 221601180004, 221601180005, 221601180006, 221601180007, 221601180008, 221601180009, 221601180010, 221601180011, 221601180012, 221601180013, 221601180014, 221601180015, 221601180016, 221601180017, 221601180018, 221601180019, 221601180020); Lot No. 63271202 (Serial Numbers: 221601220001, 221601220002, 221601220003, 221601220004, 221601220005); Lot No. 63258039 (Serial Numbers: 221602060001, 221602060002, 221602060003, 221602060004, 221602060005, 221602060006, 221602060007, 221602060008, 221602060009, 221602060010, 221602060011, 221602060012, 221602060013, 221602060014, 221602060015, 221602060016, 221602060017, 221602060018, 221602060019, 221602060020); Lot No. 63278388 (Serial Numbers: 221602150001, 221602150002, 221602150003, 221602150004, 221602150005, 221602150006, 221602150007, 221602150008, 221602150009, 221602150010, 221602150011, 221602150012, 221602150013, 221602150014, 221602150015, 221602150016, 221602150017, 221602150018, 221602150019, 221602150020); Lot No. 63278436 (Serial Numbers: 221602240001, 221602240002, 221602240003, 221602240004, 221602240005, 221602240006, 221602240007, 221602240008, 221602240009, 221602240010, 221602240011, 221602240012, 221602240013, 221602240014, 221602240015, 221602240016, 221602240017, 221602240018, 221602240019, 221602240020); Lot No. 63314121 (Serial Numbers: 221603090001, 221603090002, 221603090003); Lot No. 63314118 (Serial Numbers: 221603110001, 221603110002, 221603110003); Lot No. 63324625 (Serial Numbers: 221603220001, 221603220002, 221603220003); Lot No. 63336959 (Serial Numbers: 221603300001, 221603300002, 221603300003, 221603300004, 221603300005, 221603300006, 221603300007, 221603300008, 221603300009, 221603300010); Lot No. 63314042 (Serial Numbers: 221603300011, 221603300012, 221603300013, 221603300014, 221603300015, 221603300016, 221603300017, 221603300018, 221603300019, 221603300020, 221603300021, 221603300022, 221603300023, 221603300024, 221603300025, 221603300026, 221603300027, 221603300028, 221603300029, 221603300030); Lot No. 63341344 (Serial Numbers: 221604040001, 221604040002, 221604040003, 221604040004, 221604040005); Lot No. 63341346 (Serial Numbers: 221604050001, 221604050002, 221604050003, 221604050004, 221604050005, 221604050006, 221604050007, 221604050008, 221604050009, 221604050010); Lot No. 63314117 (Serial Numbers: 221604220001, 221604220002, 221604220003, 221604220004, 221604220005, 221604220006, 221604220007, 221604220008, 221604220009, 221604220010, 221604220011, 221604220012, 221604220013, 221604220014, 221604220015, 221604220016, 221604220017, 221604220018, 221604220019, 221604220020); Lot No. 63352349 (Serial Numbers: 221604250001, 221604250002, 221604250003); Lot No. 63339440 (Serial Numbers: 221605020001, 221605020002, 221605020003, 221605020004, 221605020005, 221605020006, 221605020007, 221605020008, 221605020009, 221605020010, 221605020011, 221605020012, 221605020013, 221605020014, 221605020015, 221605020016, 221605020017, 221605020018, 221605020019, 221605020020); Lot No. 63343366 (Serial Numbers: 221605060001, 221605060002, 221605060003, 221605060004, 221605060005, 221605060006, 221605060007, 221605060008, 221605060009, 221605060010, 221605060011, 221605060012, 221605060013, 221605060014, 221605060015, 221605060016, 221605060017, 221605060018, 221605060019, 221605060020, 221605060021, 221605060022); Lot No. 63352347 (Serial Numbers: 221605110001, 221605110002, 221605110003, 221605110004, 221605110005); Lot No. 63339497 (Serial Numbers: 221605120001, 221605120002, 221605120003, 221605120004, 221605120005, 221605120006, 221605120007, 221605120008, 221605120009, 221605120010, 221605120011, 221605120012, 221605120013, 221605120014, 221605120015, 221605120016, 221605120017, 221605120018, 221605120019, 221605120020); Lot No. 63378855 (Serial Numbers: 221606020001, 221606020002, 221606020003); Lot No. 63369605 (Serial Numbers: 221606110001, 221606110002, 221606110003, 221606110004, 221606110005, 221606110006, 221606110007, 221606110008, 221606110009, 221606110010, 221606110011, 221606110012, 221606110013, 221606110014, 221606110015, 221606110016, 221606110017, 221606110018, 221606110019, 221606110020); Lot No. 63403010 (Serial Numbers: 221606110021, 221606110022, 221606110023); Lot No. 63403012 (Serial Numbers: 221606150001, 221606150002, 221606150003, 221606150004, 221606150005, 221606150006, 221606150007, 221606150008); Lot No. 63403026 (Serial Numbers: 221606210001, 221606210002, 221606210003, 221606210004, 221606210005, 221606210006, 221606210007, 221606210008, 221606210009, 221606210010, 221606210011, 221606210012, 221606210013, 221606210014, 221606210015, 221606210016, 221606210017, 221606210018, 221606210019, 221606210020); Lot No. 63403009 (Serial Numbers: 221606220001, 221606220002, 221606220003); Lot No. 63403024 (Serial Numbers: 221606230001, 221606230002, 221606230003, 221606230004, 221606230005, 221606230006, 221606230007, 221606230008, 221606230009, 221606230010, 221606230011, 221606230012, 221606230013, 221606230014, 221606230015, 221606230016, 221606230017, 221606230018, 221606230019, 221606230020); Lot No. 63403025 (Serial Numbers: 221606240001, 221606240002, 221606240003, 221606240004, 221606240005, 221606240006, 221606240007, 221606240008, 221606240009, 221606240010); Lot No. 63403017 (Serial Numbers: 221606240011, 221606240012, 221606240013, 221606240014, 221606240015); Lot No. 63394148 (Serial Numbers: 221606290001, 221606290002, 221606290003, 221606290004, 221606290005, 221606290006, 221606290007, 221606290008, 221606290009, 221606290010, 221606290011, 221606290012, 221606290013, 221606290014, 221606290015, 221606290016, 221606290017, 221606290018, 221606290019, 221606290020); Lot No. 63410582 (Serial Numbers: 221607050001, 221607050002, 221607050003, 221607050004, 221607050005, 221607050006, 221607050007, 221607050008, 221607050009, 221607050010, 221607050011, 221607050012, 221607050013, 221607050014, 221607050015); Lot No. 63422767 (Serial Numbers: 221607080001, 221607080002, 221607080003, 221607080004, 221607080005, 221607080006, 221607080007, 221607080008, 221607080009, 221607080010, 221607080011, 221607080012, 221607080013, 221607080014, 221607080015, 221607080016, 221607080017, 221607080018, 221607080019, 221607080020); Lot No. 63410583 (Serial Numbers: 221607210001, 221607210002, 221607210003, 221607210004, 221607210005, 221607210006, 221607210007, 221607210008, 221607210009, 221607210010); Lot No. 63410585 (Serial Numbers: 221607220001, 221607220002, 221607220003, 221607220004, 221607220005, 221607220006, 221607220007, 221607220008, 221607220009, 221607220010); Lot No. 63394176 (Serial Numbers: 221607260001, 221607260002, 221607260003, 221607260004, 221607260005, 221607260006, 221607260007, 221607260008, 221607260009, 221607260010, 221607260011, 221607260012, 221607260013, 221607260014, 221607260015, 221607260016, 221607260017, 221607260018, 221607260019, 221607260020); Lot No. 63430499 (Serial Numbers: 221608080001, 221608080002, 221608080003, 221608080004, 221608080005, 221608080006, 221608080007, 221608080008, 221608080009, 221608080010, 221608080011, 221608080012, 221608080013, 221608080014, 221608080015, 221608080016, 221608080017, 221608080018, 221608080019, 221608080020); Lot No. 63437710 (Serial Numbers: 221608120001, 221608120002, 221608120003, 221608120004, 221608120005); Lot No. 63436338 (Serial Numbers: 221608160001, 221608160002, 221608160003, 221608160004, 221608160005); Lot No. 63445193 (Serial Numbers: 221608170001, 221608170002, 221608170003, 221608170004, 221608170005, 221608170006, 221608170007, 221608170008, 221608170009, 221608170010, 221608170011, 221608170012, 221608170013, 221608170014, 221608170015, 221608170016, 221608170017, 221608170018, 221608170019, 221608170020); Lot No. 63430540 (Serial Numbers: 221608190001, 221608190002, 221608190003, 221608190004, 221608190005, 221608190006, 221608190007, 221608190008, 221608190009, 221608190010, 221608190011, 221608190012, 221608190013, 221608190014, 221608190015, 221608190016, 221608190017, 221608190018, 221608190019, 221608190020); Lot No. 63445194 (Serial Numbers: 221608230001, 221608230002, 221608230003, 221608230004, 221608230005, 221608230006, 221608230007, 221608230008, 221608230009, 221608230010, 221608230011, 221608230012, 221608230013, 221608230014, 221608230015, 221608230016, 221608230017, 221608230018, 221608230019, 221608230020); Lot No. 63455066 (Serial Numbers: 221609010001, 221609010002, 221609010003, 221609010004, 221609010005, 221609010006, 221609010007, 221609010008, 221609010009, 221609010010, 221609010011, 221609010012, 221609010013, 221609010014, 221609010015, 221609010016, 221609010017, 221609010018, 221609010019, 221609010020); Lot No. 63474281 (Serial Numbers: 221609080001, 221609080002, 221609080003, 221609080004, 221609080005, 221609080006, 221609080007, 221609080008, 221609080009, 221609080010, 221609080011, 221609080012, 221609080013, 221609080014, 221609080015, 221609080016, 221609080017, 221609080018, 221609080019, 221609080020); Lot No. 63474283 (Serial Numbers: 221609080021, 221609080022, 221609080023, 221609080024, 221609080025, 221609080026); Lot No. 63474284 (Serial Numbers: 221609150001, 221609150002, 221609150003, 221609150004, 221609150005, 221609150006, 221609150007, 221609150008); Lot No. 63474287 (Serial Numbers: 221609210001, 221609210002, 221609210003, 221609210004, 221609210005, 221609210006, 221609210007, 221609210008, 221609210009, 221609210010); Lot No. 63474285 (Serial Numbers: 221610010001, 221610010002, 221610010003, 221610010004, 221610010005, 221610010006, 221610010007, 221610010008, 221610010009, 221610010010, 221610010011, 221610010012, 221610010013, 221610010014, 221610010015); Lot No. 63455098 (Serial Numbers: 221610050001, 221610050002, 221610050003, 221610050004, 221610050005, 221610050006, 221610050007, 221610050008, 221610050009, 221610050010, 221610050011, 221610050012, 221610050013, 221610050014, 221610050015, 221610050016, 221610050017, 221610050018, 221610050019, 221610050020); Lot No. 63474282 (Serial Numbers: 221610110001, 221610110002, 221610110003, 221610110004, 221610110005, 221610110006, 221610110007, 221610110008, 221610110009, 221610110010, 221610110011, 221610110012, 221610110013, 221610110014, 221610110015, 221610110016, 221610110017, 221610110018, 221610110019, 221610110020); Lot No. 63484747 (Serial Numbers: 221610140001, 221610140002, 221610140003, 221610140004, 221610140005); Lot No. 63482404 (Serial Numbers: 221610180001, 221610180002, 221610180003, 221610180004, 221610180005, 221610180006, 221610180007, 221610180008, 221610180009, 221610180010, 221610180011, 221610180012, 221610180013, 221610180014, 221610180015, 221610180016, 221610180017, 221610180018, 221610180019, 221610180020); Lot No. 63482405 (Serial Numbers: 221610200001, 221610200002, 221610200003, 221610200004, 221610200005, 221610200006, 221610200007, 221610200008, 221610200009, 221610200010, 221610200011, 221610200012, 221610200013, 221610200014, 221610200015, 221610200016, 221610200017, 221610200018, 221610200019, 221610200020); Lot No. 63482408 (Serial Numbers: 221611210001, 221611210002, 221611210003, 221611210004, 221611210005, 221611210006, 221611210007, 221611210008, 221611210009, 221611210010, 221611210011,221611210012, 221611210013, 221611210014, 221611210015, 221611210016, 221611210017, 221611210018, 221611210019, 221611210020); Lot No. 63501470 (Serial Numbers: 221611210021, 221611210022, 221611210023, 221611210024, 221611210025); Lot No. 63501471 (Serial Numbers: 221611210021, 221611210022, 221611210023, 221611210024, 221611210025); Lot No. 63501459 (Serial Numbers: 221611280001, 221611280002, 221611280003, 221611280004, 221611280005, 221611280006, 221611280007, 221611280008, 221611280009, 221611280010, 221611280011, 221611280012, 221611280013, 221611280014, 221611280015, 221611280016, 221611280017, 221611280018, 221611280019, 221611280020); Lot No. 63501486 (Serial Numbers: 221612020001, 221612020002, 221612020003, 221612020004, 221612020005, 221612020006, 221612020007, 221612020008, 221612020009, 221612020010, 221612020011, 221612020012, 221612020013, 221612020014, 221612020015, 221612020016, 221612020017, 221612020018, 221612020019, 221612020020); Lot No. 63501469 (Serial Numbers: 221612030001, 221612030002, 221612030003, 221612030004, 221612030005, 221612030006, 221612030007, 221612030008, 221612030009, 221612030010, 221612030011, 221612030012, 221612030013, 221612030014, 221612030015, 221612030016, 221612030017, 221612030018); Lot No. 63531693 (Serial Numbers: 221612050001, 221612050002, 221612050003, 221612050004, 221612050005); Lot No. 63501509 (Serial Numbers: 221612070001, 221612070002, 221612070003, 221612070004, 221612070005, 221612070006, 221612070007, 221612070008, 221612070009, 221612070010, 221612070011, 221612070012, 221612070013, 221612070014, 221612070015, 221612070016, 221612070017, 221612070018, 221612070019, 221612070020); Lot No. 63501547 (Serial Numbers: 221612100001, 221612100002, 221612100003, 221612100004, 221612100005, 221612100006, 221612100007, 221612100008, 221612100009, 221612100010, 221612100011, 221612100012, 221612100013, 221612100014, 221612100015, 221612100016, 221612100017, 221612100018, 221612100019, 221612100020); Lot No. 63501493 (Serial Numbers: 221612130001, 221612130002, 221612130003, 221612130004, 221612130005, 221612130006, 221612130007, 221612130008)

Distribution pattern: Worldwide Distribution: US (nationwide) to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, including Guam; and countries to Australia, Brazil, Canada, Chile, China, Denmark, Dominican, El Salvador, England, Finland, France, Hong Kong, India, Italy, Japan, Malaysia, Mexico, Netherlands, Panama, Singapore, Sweden, Taiwan, and Thailand..

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Updated on-device label and 3 pages of an updated Operator/Service Manual. Also, decrease from 3.8 meters (m) to 1.0 separation distance between the device and RF communication equipment.