FDA Device recall Z-0552-2019
StealthStation Cranial and Synergy Cranial Depth Gauge: StealthStation Cranial Optical Pocket Guide - Instructions for cranial procedures u…
- FDA Device
- Class I
- terminated
- Published 2019-01-09
On 2019-01-09 the FDA classified a Class I recall of StealthStation Cranial and Synergy Cranial Depth Gauge: StealthStation Cranial Optical Pocket Guide - Instructions for cranial procedures u… by Medtronic Navigation, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0552-2019 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2018-09-26 |
| Published | 2019-01-09 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Medtronic Navigation |
| Distribution | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, 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, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY |
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.
Reason
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.
Identifiers
| code_info | Product Number/CFN Affected Software Versions 9733763 2.2.0, 2.2.5, 2.2.6, 2.2.7…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-G0 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0552-2019%22
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