FDA Medical Device Recalls (openFDA)
Mazor Robotics Ltd: MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1
- Recall number
- Z-0101-2024
- Recalling firm
- Mazor Robotics Ltd
- Product
- MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1
- Status
- Open, Classified
- Initiated
- 2023-09-05
- Posted
- 2023-10-12
- Terminated
- not on file
- Reason
- Software update
- Root cause
- Software design
- Action
- 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.
- Quantity
- 324 devices
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K203005"]
- PMA numbers
- not on file
- Product code
- OLO
- Firm FEI
- 3005075696
- Firm city
- Caesarea
- Firm state
- not on file
- Firm country
- Israel
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28