MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1

This recall is currently active, issued October 12, 2023.

Recall Initiated: September 5, 2023
Posted: October 12, 2023
Recall Number: Z-0101-2024
Quantity: 324 devices
Official Source: View on FDA website ↗

Reason for Recall

Software update

Distribution

US Nationwide distribution.

Lot / Code Info

GTIN 07290109180465, Serial Numbers: 4000770717, 4000800717, 4000810817, 4000820817, 4000830817, 4000840817, 4000850817, 4000870817, 4000880817, 4000890917, 4000900917, 4000910917, 4000920917, 4000930917, 4000940917, 4000951017, 4000961017, 4000971017, 4000981017, 4000991017, 4001001017, 4001011117, 4001041117, 4001061117, 4001071217, 4001081217, 4001091217, 4001101217, 4001111217, 4001121217, 4001130118, 4001140118, 4001150118, 4001160118, 4001180118, 400-26-112016, 400-27-112016, 400-29-122016, 400-30-122016, 400-31-122016, 400-36-122016, 400-38-122016, 400-44-022017, 400-47-022017, 400-48-022017, 400-50-032017, 400-51-032017, 400-53-032017, 400-54-032017, 400-55-032017, 400-56-032017, 400-59-052017, 400-60-052017, 400-61-062017, 400-63-062017, 400-64-062017, 400-65-062017, 400-67-062017, 400-68-062017, 400-69-062017, 400-71-062017, 400-72-062017, 400-73-062017, 400-75-062017, 400-78-072017, 400-79-072017; GTIN 07290109181158, Serial Numbers: 4001200218, 4001210218, 4001270318, 4001280318, 4001300518, 4001310518, 4001320518, 4001330618, 4001360618, 4001370718, 4001390818, 4001400818, 4001410918, 4001430918, 4001440918, 4001450918, 4001470918, 4001481018, 4001501018, 4001511018, 4001521118, 4001531118, 4001541118, 4001551118, 4001561118, 4001571118, 4001601218, 4001611218, 4001631218, 4001641218, 4001651218, 4001680119, 4001690119, 4001710119, 4001740219; GTIN 07290109183213, Serial Numbers: 4001770219, 4001780219, 4001790219, 4001800219, 4001820219, 4001840219, 4001850219, 4001900319, 4001920419, 4001940419, 4001960419, 4001970419, 4001980419, 4001990419, 4002000419, 4002010419, 4002020419, 4002060519, 4002070519, 4002080519, 4002090519, 4002100519, 4002140619, 4002150619, 4002160619, 4002170619, 4002180619, 4002220719, 4002230819, 4002240819, 4002250819, 4002260819, 4002270819, 4002280819, 4002290819, 4002300819, 4002310919, 4002330919, 4002340919, 4002350919, 4002360919, 4002370919, 4002380919, 4002390919, 4002400919, 4002411019, 4002421019, 4002441019, 4002451019, 4002461019, 4002511119, 4002531119, 4002541119, 4002551119, 4002561119, 4002591119, 4002611219, 4002621219, 4002631219, 4002641219, 4002661219, 4002681219, 4002720120, 4002730120, 4002740120, 4002750120, 4002790120, 4002810120, 4002820120, 4002830220, 4002850220, 4002880220, 4002900220, 4002950220, 4002960220, 4002990220, 4003000320, 4003020320, 4003030320, 4003040320, 4003050320, 4003060320, 4003080320, 4003100320, 4003120320, 4003130320, 4003150320, 4003160320, 4003170320, 4003180320, 4003190320, 4003200320, 4003250520, 4003260520, 4003270520, 4003290520, 4003300620, 4003310520, 4003330620, 4003340620, 4003350620, 4003360620, 4003390820, 4003410920, 4003420920, 4003430920, 4003440920, 4003450920, 4003460920, 4003471120, 4003481120, 4003491120, 4003501120, 4003541120, 4003550121, 4003560121, 4003640221, 4003680421, 4003700521, 4003710621, 4003720521, 4003730621, 4003740621, 4003760621, 4003780621, 4003800821, 4003810821, 4003820821, 4003840821, 4003850821, 4003860821, 4003870821, 4003880821, 4003930921, 4003940921, 4003950921, 4003960921, 4003970921, 4003981021, 4003991021, 4004001021, 4004011021, 4004021021, 4004031021, 4004041021, 4004061121, 4004081121, 4004101121, 4004131121, 4004141121, 4004151121, 4004181221, 4004231221, 4004241221, 4004270122, 4004290122, 4004300122, 4004310122, 4004320122, 4004330122, 4004340122, 4004350122, 4004370122, 4004380122, 4004410222, 4004500322, 4004520322, 4004540322, 4004550322, 4004560322, 4004600322, 4004610322, 4004620322, 4004630322, 4004650322, 4004660322, 4004670322, 4002050419R, 4002860220R; GTIN 07290115751376, Serial Numbers: 4004680322, 4004700322, 4004710522, 4004790522, 4004810522, 4004830522, 4004870522, 4004910622, 4004950622, 4005030722, 4005080722, 4005130822, 4005140822, 4005150822, 4005200822, 4005210922, 4005220922, 4005230922, 4005240922, 4005250922, 4005290922, 4005330922, 4005340922, 4005350922, 4005360922, 4005401122, 4005431122, 4005451122, 4005471122, 4005481122, 4005501122, 4005521222, 4005551222, 4005561222, 4005571222, 4005621222, (new 04/11/2024): 4004251221, 4004440222, 4004930622, 4004980622, 4005491122, 4005960223, 4006070223, 4006750823

Root Cause

Software design

Action Taken

IMazor Robotics, Ltd. issued an URGENT: Medical Devices Software Correction notice to its consignees on 09/05/2023 via 2-day tracked mailing and in Puerto Rico it was hand delivered by the regional field representative. The notice explained the anomalies to be corrected and the potential health hazards associated with the anomalies. Medtronic field service engineers will be updating all Mazor X" systems from version 4.2.2 or 5.0.1 to version 5.1.1 in the US at your next planned service visit, or earlier.