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U.S. Department of Health and Human Services

Class 1 Device Recall StealthStationTM Cranial and SynergyTM Cranial Depth Gauge

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  Class 1 Device Recall StealthStationTM Cranial and SynergyTM Cranial Depth Gauge see related information
Date Initiated by Firm September 26, 2018
Date Posted December 29, 2018
Recall Status1 Open3, Classified
Recall Number Z-0552-2019
Recall Event ID 81214
510(K)Number K150216  K153660  
Product Classification Neurological stereotaxic Instrument - Product Code HAW
Product StealthStation Cranial and Synergy Cranial Depth Gauge:

StealthStation 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) Note: This 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.
Code Information Product Number/CFN Affected Software Versions 9733763 2.2.0, 2.2.5, 2.2.6, 2.2.7 Synergy Cranial 9735585 3.0.0, 3.0.1, 3.0.2, 3.1.0 StealthStation S7 Cranial  Kit CFN and UDI: CFN GTIN Description 9733763 00613994408174 SOFTWARE, 9733763, SYNERGY CRANIAL S7 9734068 00613994546081 SFTWR KIT 9734068 SYN CRANI S7 PLNG STN 9734068 00643169038110 SFTWR KIT 9734068 SYN CRANI S7 PLNG STN 9733937 00613994467102 Software Kit 9733937 Synergy Cranial S7 9733937 00643169037946 Software Kit 9733937 Synergy Cranial S7 9733928 00613994467126 Upgrade Prgm 9733928 Treon to S7 220V 9734261 00613994792884 UPGRD PRGM 9734261 StealthStation S7 9734261-G02 00643169510531 UPGRD PRGM 9734261 StealthStation S7 9734849 00613994944986 UPGD PRGM 9734849 S7 CPTL ENH PRGM 9735064 00643169192140 UPGRD PRGM 9735064 KAISER TREON TO S7 9735328 00643169332645 UPGRD PRGM 9735328 Stealth S7 Touch¿ 9735328-G02 00643169510548 UPGRD PRGM 9735328 Stealth S7 Touch 9733937-G02 00643169353305 Software Kit 9733937 Synergy Cranial S7 9733763-G03 00643169503311 SOFTWARE, 9733763, SYNERGY CRANIAL S7 9733937-G03 00643169481275 SOFTWARE KIT 9733937 SYNERGY CRANIAL S7 9733928-G02 00643169502611 UPGRADE PRGM 9733928 TREON TO S7 220V 9734261-G03 00643169641167 UPGRD PRGM 9734261 StealthStation S7 9734849-G02 00643169513754 UPGD PRGM 9734849 S7 CPTL ENH PRGM 9735064-G02 00643169510579 UPGRD PRGM 9735064 KAISER TREON TO S7 9735328-G03 00643169641174 UPGRD PRGM 9735328 Stealth S7 Touch 9735065-G04 00643169490475 UPGRADE KIT 9735065 KAISER S7 9735070-G04 00643169490482 UPGRADE KIT 9735070 CRANIAL AXIEM S7 9733937-G04 00643169505759 SW KIT 9733937 SYNERGY CRANIAL S7 EU-NW 9733937-G05 00643169505797 SW KIT 9733937 SYNERGY CRANIAL S7 EU-SW 9733937-G06 00643169505766 SW KIT 9733937 SYNERGY CRANIAL S7 SCAND 9733937-G07 00643169505773 SW KIT 9733937 SYNERGY CRANIAL S7 EU-E 9733937-G08 00643169505780 SW KIT 9733937 SYNERGY CRANIAL S7 EU-SE 9734068-G02 00643169481268 SFTWR KIT 9734068 SYN CRANI S7 PLNG STN 9734068-G03 00643169510562 SW KIT 9734068 SYN CRAN S7 PLNG STN EUNW 9734068-G04 00643169510586 SW KIT 9734068 SYN CRAN S7 PLNG STN EUSW 9734068-G05 00643169510593 SWKIT 9734068 SYN CRAN S7 PLNG STN SCAND 9734068-G06 00643169510609 SW KIT 9734068 SYN CRAN S7 PLNG STN EU-E 9734068-G07 00643169510616 SW KIT 9734068 SYN CRAN S7 PLNG STN EUSE 9731975 00885074238241 TUMOR RESECTION PACK, 9731975, AxiEM CR 9733300 00613994231031 SHUNT PACK 9733300 AXIEM NON-INVASIVE 9735585 00643169625532 SOFTWARE 9735585 STEALTHSTATION CRANIAL 9735586 00643169625570 SW KIT 9735586 STEALTHSTATION CRANIAL 9735586 00643169777101 SW KIT 9735586 STEALTHSTATION CRANIAL 9735586-G02 00643169625587 SW KIT 9735586 STEALTH CRANIAL EU-NW 9735586-G03 00643169625594 SW KIT 9735586 STEALTH CRANIAL EU-SW 9735586-G04 00643169625600 SW KIT 9735586 STEALTH CRANIAL SCAND 9735586-G05 00643169625617 SW KIT 9735586 STEALTH CRANIAL EU-E 9735586-G06 00643169625624 SW KIT 9735586 STEALTH CRANIAL EU-SE 9735587 00643169625631 SW KIT 9735587 STEALTH CRANIAL PLNG STN 9735587-G02 00643169625648 SWKIT 9735587 STEALTH CRAN PLNG STN EUNW 9735587-G03 00643169625655 SWKIT 9735587 STEALTH CRAN PLNG STN EUSW 9735587-G04 00643169625662 SWKIT 9735587 STEALTH CRAN PLN STN SCAND 9735587-G05 00643169625679 SWKIT 9735587 STEALTH CRAN PLNG STN EU-E 9735587-G06 00643169625686 SWKIT 9735587 STEALTH CRAN PLNG STN EUSE 9735585-G02 00763000095741 SOFTWARE 9735585 STEALTHSTATION CRANIAL 9735586-G07 00763000095758 SW KIT 9735586 STEALTHSTATION CRANIAL 9735586-G08 00763000095765 SW KIT 9735586 STEALTH CRANIAL EU-NW 9735586-G09 00763000095772 SW KIT 9735586 STEALTH CRANIAL EU-SW 9735586-G10 00763000095789 SW KIT 9735586 STEALTH CRANIAL SCAND 9735586-G11 00763000095796 SW KIT 9735586 STEALTH CRANIAL EU-E 9735586-G12 00763000095802 SW KIT 9735586 STEALTH CRANIAL EU-SE 9735587-G07 00763000095819 SW KIT 9735587 STEALTH CRANIAL PLNG STN 9735587-G08 00763000095826 SWKIT 9735587 STEALTH CRAN PLNG STN EUNW 9735587-G09 00763000095833 SWKIT 9735587 STEALTH CRAN PLNG STN EUSW 9735587-G10 00763000095840 SWKIT 9735587 STEALTH CRAN PLN STN SCAND 9735587-G11 00763000095857 SWKIT 9735587 STEALTH CRAN PLNG STN EU-E 9735587-G12 00763000095864 SWKIT 9735587 STEALTH CRAN PLNG STN EUSE 
Recalling Firm/
Manufacturer		 Medtronic Navigation, Inc.
826 Coal Creek Cir
Louisville CO 80027-9710
For Additional Information Contact Tom F. Reimann
720-890-3241
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Under Investigation by firm
Action On 09/26/2018, the firm sent an Urgent Medical Device Correction Notification to all US customers informing them of potential inaccuracy during biopsy procedures using the StealthStation S7 Depth Gauge feature on StealthStation S7 and i7 systems running Synergy Cranial and StealthStation Cranial software that could result in healthy tissue being biopsied. The notification letter stated, In navigated biopsy procedures, where the Navigate Projection feature is used and the projection is longer than the length of the plan, the graphical Biopsy Depth Gauge feature can display inaccurate information. The Biopsy Needle Depth Gauge is a numerical and graphical representation of the needle cutting window in the Guidance view quadrant to assist in visualization of the cutting window position. During a biopsy procedure, the monitor shows four quadrants (Trajectory 1, Trajectory 2, Guidance, and Probes Eye views) as well as the Biopsy Depth Gauge. The overlay of the Biopsy Needle within the anatomical views accurately indicates the correct tip location of the instrument. However, if Navigate Projection is selected, and the projection is longer than the length of the plan, then the Biopsy Depth Gauge graphical display inaccurately depicts that the tip of the instrument has not yet reached the plan target. Since 2011, Medtronic has received seven (7) complaints potentially related to this software anomaly, one in which healthy tissue was biopsied. The image on page two contains an example of the error use case. All views correctly show that the instrument is past the target, and the Depth Gauge correctly displays the past-target measurement of -63, which indicates the instrument tip has advanced 63 mm beyond the intended target. However, the graphical Biopsy Needle cut window appears not to have advanced to the target position. If the surgical team relies solely on the graphical representation in the Biopsy Depth Gauge feature and disregards other factors (such as
Quantity in Commerce 5487 impacted systems
Distribution US: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY OUS: Albania, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Bosnia, Brazil, Brunei Darussalam, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Honduras, Hong Kong, Hungary, Iceland, India, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Martinique, Mexico, Moldova, Morocco, Myanmar, Nepal, Netherland, New Zealand, Nicaragua, Norway, Pakistan, Peru, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = HAW and Original Applicant = MEDTRONIC NAVIGATION, INC.
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