Reported Jan 9, 2019 · Terminated
StealthStation Cranial and Synergy Cranial Depth Gauge: StealthStation Cranial Optical Pocket Guide - Instructions for…
Medtronic Navigation, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.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. · 826 Coal Creek Cir · Louisville, CO · 80027-9710
Is this the product you have?
- StealthStation
- Cranial and Synergy Cranial Depth GaugeStealthStation Cranial Optical Pocket Guide - Instructions for cranial procedures using optical localization StealthStation Cranial version 3.0, 3.1 CE 0344 Rx Only 2018-02 9735489 Revision 3 Medtronic Navigation, Inc
- Biopsy Needle Kit (9733068) NoteThis device is an accessory to your StealthStation System. . . The Biopsy Needle is a presterilized , single-use, side-cutting needle for cranial tissue biopsies. CE 0344 Rx Only 2017-05 9733068-01 Medtronic Navigation, Inc
- Lot codes and dates
62 of 62 products
Products covered by this recall Model / number Barcodes Product as published 973376300613994408174SOFTWARE, 9733763, SYNERGY CRANIAL S7 973406800613994546081SFTWR KIT 9734068 SYN CRANI S7 PLNG STN 973406800643169038110SFTWR KIT 9734068 SYN CRANI S7 PLNG STN 973393700613994467102Software Kit 9733937 Synergy Cranial S7 973393700643169037946Software Kit 9733937 Synergy Cranial S7 973392800613994467126Upgrade Prgm 9733928 Treon to S7 220V 973426100613994792884UPGRD PRGM 9734261 StealthStation S7 9734261-G0200643169510531UPGRD PRGM 9734261 StealthStation S7 973484900613994944986UPGD PRGM 9734849 S7 CPTL ENH PRGM 973506400643169192140UPGRD PRGM 9735064 KAISER TREON TO S7 973532800643169332645UPGRD PRGM 9735328 Stealth S7 Touch¿ 9735328-G0200643169510548UPGRD PRGM 9735328 Stealth S7 Touch 9733937-G0200643169353305Software Kit 9733937 Synergy Cranial S7 9733763-G0300643169503311SOFTWARE, 9733763, SYNERGY CRANIAL S7 9733937-G0300643169481275SOFTWARE KIT 9733937 SYNERGY CRANIAL S7 9733928-G0200643169502611UPGRADE PRGM 9733928 TREON TO S7 220V 9734261-G0300643169641167UPGRD PRGM 9734261 StealthStation S7 9734849-G0200643169513754UPGD PRGM 9734849 S7 CPTL ENH PRGM 9735064-G0200643169510579UPGRD PRGM 9735064 KAISER TREON TO S7 9735328-G0300643169641174UPGRD PRGM 9735328 Stealth S7 Touch - Amount recalled
- 5487 impacted systems
Where it was sold
Why it was recalled
Stop using this product now
An incorrect display of the Biopsy Depth Gauge graphical representation in the Guidance View using Cranial software, which resulted in the biopsy of healthy tissue.
Using this product could cause serious injury, illness or death — stop using it now.
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