Medtronic Navigation, Inc. recalls StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems
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…
Read the official notice →- Date
- 2023-06-14
- Country
- United States
- Brand
- Medtronic Navigation
- Product
- StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems
- Classification
- Class I
- Units
- US Distribution: PR. OUS (foreign) distribution: ARGENTINA, AUSTRALIA,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
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- Check the product name, strength and lot number against the official notice.
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General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Medtronic Navigation recalls
- 2024-05-15
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FDA · DeviceMedtronic Navigation, Inc.Worldwide - US Nationwide distribution in the states of AK, AL, AZ, CA and the…Official notice → - 2023-11-15
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Medtronic Navigation, Inc. recalls StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The StealthStation System, with StealthStation Cranial software, is…
Due to a software anomaly which potentially could result in the surgical planning data shifting to an unintended location.
FDA · DeviceMedtronic Navigation, Inc.Worldwide Distribution: U.S. (nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, DE,…Official notice → - 2023-06-14
- US
Medtronic Navigation, Inc. recalls StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systems
During non-axial/some axial exams, software anomalies occur during procedures affecting depth gauge graphic displays for cranial biopsy; causing displays to no longer synchronize with other navigational information…
FDA · DeviceMedtronic Navigation, Inc.Worldwide Distibution: US (nationwide): OH, IL, CA, MI, FL, LA, OK, WA, AR,…Official notice → - 2023-02-08
- US
Medtronic Navigation, Inc. recalls AxiEM" Non-Invasive Patient Tracker
Due to increasing complaint trend for the Non-Invasive Patient Tracker system where complaints analysis indicates that users are unable to successfully verify their navigation instruments during image-guided surgery.
FDA · DeviceMedtronic Navigation, Inc.Worldwide - U.S. distribution including in the states of AL, AR, AZ, CA, CO,…Official notice → - 2023-01-18
- US
Medtronic Navigation, Inc. recalls RadiaLux Lighted Retractor (Pink), REF: 50-101-1
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FDA · DeviceMedtronic Navigation, Inc.US Nationwide distribution including in the states of OH, CA, FL, NJ, NY, MN,…Official notice →
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DePuy Mitek, Inc., a Johnson & Johnson Co. recalls DePuy Mitek BIOKNOTLESS Plus w/ Panacryl-Indicated for use in soft tissue to bone fixation in association with…
IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS¿ Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken…
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Elekta, Inc. recalls Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil.
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