Recall Z-0383-2022— Medtronic Navigation, Inc.
Class I · Ongoing
Class I FDA medical device recall by Medtronic Navigation, Inc., initiated 2021-11-11. It names 2 FDA 510(k) clearances: K190672, K150216. Product: Stealthstation System w/ Stealthstation Cranial Software 3.1.1,3.1.2,3.1. or SynergyCranial Software. Synergy Cranial, Model: 9733763, and StealthStation Cranial, Model: 9735585. Reason: Cranial biopsy procedure software can enter a state where the biopsy depth gauge is no longer synchronized with the rest of the navigational information on the screen and may display an incorrect position of the biopsy needle, which may result in prolonged procedure, the need for additional surgical procedure, tissue injury..
- Recalling firm
- Medtronic Navigation, Inc.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2021-11-11
- Firm location
- Louisville, CO, United States
510(k) clearances named in this recall
2 on FDA's record- K190672 — StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1
- 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 System w/ Stealthstation Cranial Software 3.1.1,3.1.2,3.1. or SynergyCranial Software. Synergy Cranial, Model: 9733763, and StealthStation Cranial, Model: 9735585
Reason for recall
Cranial biopsy procedure software can enter a state where the biopsy depth gauge is no longer synchronized with the rest of the navigational information on the screen and may display an incorrect position of the biopsy needle, which may result in prolonged procedure, the need for additional surgical procedure, tissue injury.
Data sourced from openFDA. This site is unofficial and independent of the FDA.