Recall Z-1666-2023— Medtronic Navigation, Inc.
Class I · Ongoing
Class I FDA medical device recall by Medtronic Navigation, Inc., initiated 2023-04-11. It names 4 FDA 510(k) clearances: K221087, K190672, K153660 and 1 more. Product: StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems. Reason: In nonaxial/some axial exams if surgical plan utilized, Target Guidance selected, tip projection utilized, Navigate Projection enabled, software anomaly may occur during tumor resection/shunt placement/deep brain stimulation, where distance to/past target text no longer synchronized with navigation information, inaccurate value displayed; may result in prolonged/additional procedure, tissue injury.
- Recalling firm
- Medtronic Navigation, Inc.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2023-04-11
- Firm location
- Lafayette, CO, United States
510(k) clearances named in this recall
4 on FDA's record- K221087 — Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4
- K190672 — StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1
- K153660 — StealthStation System with Cranial Software
- K150216 — Synergy Cranial
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems
Reason for recall
In nonaxial/some axial exams if surgical plan utilized, Target Guidance selected, tip projection utilized, Navigate Projection enabled, software anomaly may occur during tumor resection/shunt placement/deep brain stimulation, where distance to/past target text no longer synchronized with navigation information, inaccurate value displayed; may result in prolonged/additional procedure, tissue injury
Data sourced from openFDA. This site is unofficial and independent of the FDA.