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 (973306
Check against the official notice below — it lists the full affected range.
Medtronic Navigation, Inc. is recalling approximately 5,487 StealthStation Cranial and Synergy Cranial systems due to an incorrect display of the Biopsy Depth Gauge in the software's Guidance View. This display error resulted in biopsies of healthy tissue being performed. The affected systems were distributed across the United States, U.S. territories, and multiple countries internationally, and involve specific software versions from 2.2.0 through 3.1.0 depending on the system model.
The recall document does not specify a remedy or recommended corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. 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 Quantity: 5487 impacted systems Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.