Reported Jul 10, 2019 · Terminated
Medtronic 0-arm TM 1000 Imaging Systems: Bl-700-00027-XXX and B1-700-00028-XXX (where XXX indicates the system…
Medtronic Navigation, Inc.-Littleton
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: Medtronic Navigation, Inc.-Littleton · 300 Foster St · Littleton, MA · 01460-2017
Is this the product you have?
Medtronic 0-arm TM 1000 Imaging Systems: Bl-700-00027-XXX and B1-700-00028-XXX (where XXX indicates the system voltage): Product Name Model#/ CFN OARM ASSY 8170000027 SYSTEM PRODUCT BI70000027 OARM ASSY BI70000027R SYS PRODUCT RWK BI70000027R BASE OARM 8170000027100 SYSTEM !DOV BI70000027100 BASE OARM Bl70000027100R SYSTEM lOOV RWK Bl70000027100R BASE OARM 8170000027120 SYSTEM
3 of 3 products
| Model / number | Barcodes | Product as published |
|---|---|---|
120V | 8170000027120 | BASE OARM Bl70000027120R SYSTEM 120V RWK BI70000027120R BASE OARM Bl70000027230 SYSTEM |
230V | 8170000027230 | BASE OARM Bl70000027230R SYSTEM 230V RWK BI70000027230R OARM ASSY BI70000027GER SYS PRODUCT GER BI70000027GER OARM ASSY Bl70000027GERR SYS PRODUCT REFURB BI70000027GERR BASE OARM 8170000028100 SYS lOOV 8170000028100 BASE OARM BI70000028120 SYS |
120V | 8170000028120 | BASE OARM BI70000028120R 3RD EDIT REFURB BI70000028120R BASE OARM BI70000028230 SYS 230V BI70000028230 BASE OARM BI70000028230R 3RD EDIT REFURB Bl70000028230R Product Usage: The 0-arrn Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomi~ structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The 0-arm Imaging System is compatible with certain Image Guided Surgery Systems. |
- Lot codes and dates
- Serial NumbersUS:O-Arm
95 of 95 codes
0010200103R0010500112R0011300116R00117R00118R0012600128R0012900131001330013400135001380014000147001480014900152001570015800164R00167001680017000171001730017600178001790018200184R00185001860018800189001900019100199002020020500210R00211002120021400215002180021900221002220022400225002260022900232R00234R0023500236
O-Arm31800319R00333003350034100342003430034400347003480035000351003590036000362003630036500366003690037000373003770037800379003810038300385003910039200394003960039800399004000040100404004050040600408004090041000412004150041600418R
O-arm420004280042900432004330043500438R00439004410044200443004440044500446R0044700449004500045200453
O-arm4570045800461004620046500466R004690047000471004740047500476004790048000484004850048700489004900049400496004970049900500005020050300507
O-arm144 of 144 codes
5100051100512005130052300524005250052600530005310053200534005350053800539R00540005410054200543005440054600547005500055100553005540055500556005610056200564005660056700568005690057000572005730057400576005790058100582R0058300584005860058700588005920059500597005980059900600006020060300604006080061100614
O-Arm 831 B14070835 B14060836 O-arm804B14030808B14040810B14040814B14040816B14040817B14040819B14050826B14050827
123 of 123 codes
842B14070846B14070847B14070849B14070851B14070852B1407085400856B1407085700858B14080859B14080861B14080862B14090863B14080864B14080865B14080866B14080867B14080871B14090872B14090873B14090874B14090880B14090881B14090882B14090883B14090884B14090885B14100886B14100887B14100888B14100889B14100890B14100891B14100893B14100894B14100895B14110896B14110898B14110899B14110901B14110902B14110903B14110904B14120905B14120906B14120907B14120908B14120909B14120910B14120911B14120912B14120913B14120915B14120916B14120917B14120918B15010919B15010920B15010921
- B16081226 B16101239 Serial NumbersOUS
365 of 365 codes
00110R00119001210012200125001390014300144001450014600151001540016000163001720017400180R001960019700201002060020700208R0021300216002170022000223002280023000231002330023700241R0024300246R002470025000251002520025300263002640026500266002760027800279002830028400285002860028700290002910029200295003010030300320
- Serial NumbersUS:
- Amount recalled
- 832 units
Where it was sold
- Nationwide
- PR
Why it was recalled
The 0-arm 1000 Imaging System uses energy from the batteries to generate X-rays and move the system. If a charger board is not functioning properly, the batteries will not receive a full recharge of the potential capacity and results in the inability of the system to take X-rays, open the gantry, and move the system from one place to another, which may affect the ability to continue use within the operating room until the charger board and/or the batteries are replaced
This product could cause temporary or reversible health problems — stop using it.
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