Reported Mar 14, 2018 · Terminated
O-arm 1000 mobile image-intensified fluoroscopic x-ray system; (1) Model: BASE OARM Bl70000028100 SYS 100V, Product…
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?
6 of 6 products
| Model / number | Barcodes | Product as published |
|---|---|---|
| — | O-arm 1000 mobile image-intensified fluoroscopic x-ray system | |
Bl70000028100 | 00643169354418 | (1) Model: BASE OARM Bl70000028100 SYS 100V, (UDI: 00643169354418) |
Bl70000028120 | 00643169353411 | (2) Model: BASE OARM Bl70000028120 SYS 120V, (UDI: 00643169353411) |
Bl70000028120R | 00643169353459 | (3) Model: BASE OARM Bl70000028120R SYS 120V RWK, (UDI: 00643169353459) |
Bl70000028230 | 00643169353992 | (4) Model: BASE OARM Bl70000028230 SYS 230V, (UDI: 00643169353992) |
Bl70000028230R | 00643169354081 | (5) BASE OARM Bl70000028230R SYS 230V RWK, (UDI: 00643169354081) Product Usage: The O-arm 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 anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The O-arm Imaging System is compatible with certain Image Guided Surgery Systems. |
- Lot codes and dates
- Serial NumbersO-Arm 831 O-arm
102 of 102 codes
B14070845B13050682B13080716B14010771B14010779B14020790B14040813B15020929B14020789B15101034B15101041B16011100B16021102B15060987B14110904B16021105B16021106B15020941B15050972B15030949B16021111B15091028B14010774B14030797B16021112B16031114B16041137B16061190B15010926B15060988B16061196B13080721B16071207B16071213B13080722B16071215B16081234B17101333B14030803B14040814B17101445B14040817B17071466B17121536B14050830B17121544B14050829B14070857B14080865B14090881B13080718B14050824B14060833B13060683B13060698B15030948B15050971B14010781B14030802B14030805
O-arm74 of 74 codes
842B14070854B14090883B14120909B15010921B15030954B15091024B15030952B14080871B14090872B14090880B14120908B14120913B15020928B15030953B15071004B15091026B15101039B14080859B15081008B15091030B15121049B16011095B14090873B15111055B15121064B14080869B14020786B14070852B14100887B14110903B14120917B15010920B15020927B15020940B14020792B14100891B14100893B14120910B15091018B14020788B14060836B15040961B16031115B14040819B14110899B15040960B15091019B14090885B15020942B14050827B14080867B14070835B15030955B15040959B14090882B13120765B14070846B16051155B14120915
76 of 76 codes
804B14070839B15020937B15040958B15091017B14110901B13120766B14080862B14080864B14100895B14120907B14120912B15010919B15020939B13120763B13120768B14020795B14050826B14070847B14070849B14080861B14080866B14100888B15030947B15060980B15070992B15081005B15091012B16031120B16041136B13090729B14100889B14100890B17011287B14120916B13080715B16081226B16101239B14010780B16051159B15030945B14030796B14040816B14050821B13050681B13050685B14030799B15020938B16041150B14030800B14090874B14120911B14030801B14120918B16031126B15010923B16061164B14030787B15050968B14020793
- Serial Numbers
- Amount recalled
- 253
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Software update ("SW Update 3.2.1") is being implemented to address the following issues: Inability to power the system after shutdown, System stays in standalone mode, Image reconstruction, System/Pendant bootup, Dose display/report, Gantry motion, Network communication, System shutdown, and Early termination of 3D spin.
This product could cause temporary or reversible health problems — stop using it.
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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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