Reported Oct 16, 2024 · Ongoing
StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spine…
Medtronic Navigation, Inc.
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. · 200 Medtronic Drive · Lafayette, CO · 80026
Is this the product you have?
- StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spine software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures.
- Lot codes and dates
- Product Number9735762
- UDI-DI code00763000456986
- Serial NumbersS8
1,039 of 1,039 codes
420002290N06805776N07323682N07323683N07323687N07326235N07334454N07334475N07338479N07338480N07338482N07338929N07354639N07354642N07354643N07354644N07354645N07355155N07357492N07357493N07360505N07360506N07362322N07362323N07364218N07364220N07364221N07365158N07365160N07365163N07365164N07369302N07369307N07401810N07401811N07401812N07401813N07407569N07418140N07418141N07426193N07427592N07427593N07427597N07428130N07428133N07428134N07428190N07428192N07428193N07428195N07428197N07429001N07436071N07436073N07436074N07438127N07438128N07441426N07441431
728 of 728 codes
N30586197N30593951N30593961N30598453N30598455N30598460N30598463N30598464N30598465N30598469N30609087N30609088N30609089N30609090N30609091N30609092N30609094N30610354N30610355N30610356N30610357N30610822N30610823N30613055N30613056N30613057N30613058N30613629N30614065N30614066N30614067N30614068N30614069N30614071N30614072N30614952N30614955N30614956N30614957N30614958N30617616N30617624N30617629N30619777N30619779N30619780N30619781N30619791N30619792N30629829N30629830N30629831N30633466N30633467N30636361N30645242N30645243N30645248N30645250N30650691
- N31464399 N31464903 UDI-DI code00763000368494
- Serial Numbers
N07370801N07441433N07521588N08159976N08223525N08223526N08245859N11710650N29255594N29529070N29531246N29810113N29855918N29934774N30001599N30009142N30043574N30046047N30067122N30067123N30389711N30416388N30449098N30462311N30610820N30803335N30927583N30927584N31022442N31049476N31088569N31088570
- Amount recalled
- 1,801 systems
Where it was sold
Why it was recalled
Due to two software anomalies that can occur within a spine procedure. Two issues are: 1. Navigation Orientation - when lateral orientation radiographic images are taken, information may appear flipped when utilizing the system (180 degree flipped). 2. Pop-up Message - when using CT+Fluouroscopy images with a slice spacing thickness greater than 2mm, the system does not display a pop-up message indicating the slice spacing is not optimal.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Medtronic Navigation, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.