| 2024-12-04 |
Class II
|
Ongoing |
Z-1022-2025 |
Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150MM, STERILE PERCUTANEOUS REF: 97733236 Th… |
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Due to an increase in complaint that the percutaneous reference pin would not fit into the patient reference frame or percutaneous pin adapter. |
| 2024-08-22 |
Class II
|
Ongoing |
Z-0050-2025 |
StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spin… |
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Due to two software anomalies that can occur within a spine procedure. Two issues are: 1. Navigation Orientation - when lateral orientation radiographic image… |
| 2024-03-26 |
Class I
|
Ongoing |
Z-1776-2024 |
Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid fo… |
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Due to a software issue, there is the potential for a missing digit, letter, or decimal in either the "distance to target" or "tip stop point" display during na… |
| 2023-11-28 |
Class II
|
Ongoing |
Z-0699-2024 |
Medtronic, REF 9733236, Pin, 150mm, STERILE, PERCUTANEOUS |
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Their is the potential that the percutaneous pin may have a cross-pin that may render the pin unable to fit into tap cap, or too tight to remove. |
| 2023-11-28 |
Class II
|
Ongoing |
Z-0698-2024 |
Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS |
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Their is the potential that the percutaneous pin may have a cross-pin that may render the pin unable to fit into tap cap, or too tight to remove. |
| 2023-09-27 |
Class I
|
Ongoing |
Z-0188-2024 |
StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The StealthStation System, with StealthStation Cra… |
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Due to a software anomaly which potentially could result in the surgical planning data shifting to an unintended location. |
| 2023-04-11 |
Class I
|
Ongoing |
Z-1666-2023 |
StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems |
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In nonaxial/some axial exams if surgical plan utilized, Target Guidance selected, tip projection utilized, Navigate Projection enabled, software anomaly may occ… |
| 2023-04-11 |
Class I
|
Ongoing |
Z-1630-2023 |
StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systems |
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During non-axial/some axial exams, software anomalies occur during procedures affecting depth gauge graphic displays for cranial biopsy; causing displays to no … |
| 2022-12-15 |
Class II
|
Ongoing |
Z-1039-2023 |
AxiEM" Non-Invasive Patient Tracker |
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Due to increasing complaint trend for the Non-Invasive Patient Tracker system where complaints analysis indicates that users are unable to successfully verify t… |
| 2022-12-08 |
Class II
|
Ongoing |
Z-0953-2023 |
RadiaLux Lighted Retractor (Pink), REF: 50-101-1 |
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Defect in sterile pouch seal, incomplete seal, of lighted Retractors, increases the risk of contamination, which can lead to post-operative infection. |
| 2022-10-14 |
Class II
|
Ongoing |
Z-0244-2023 |
Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10MM TIP product. Used to necrotize or coagul… |
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Due to a defect in the outer pouch sterile seal |
| 2021-11-11 |
Class I
|
Ongoing |
Z-0383-2022 |
Stealthstation System w/ Stealthstation Cranial Software 3.1.1,3.1.2,3.1. or SynergyCranial Software. Synergy Crania… |
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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 … |
| 2021-11-09 |
Class II
|
Ongoing |
Z-0417-2022 |
Stealth Autoguide Tracker, Model: 28248, which is an instrument in the Stealth Autoguide Basic Instrument Kit, Mode: 973… |
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A tracker that holds and guides neurosurgical surgical instruments may be subject to separation/weld failure, where the tracker connects to the instrument tube.… |
| 2020-06-05 |
Class II
|
Terminated |
Z-2707-2020 |
StealthStation" S7 System with Polaris Spectra Camera part number PSU 9733437 - Product Usage: are intended as an aid fo… |
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There is a potential for specific camera units to be affected by a characterization issue during manufacturing that results in inaccurate navigation while utili… |