PlainRecordsStealthStation Cranial Software…
- Reason
- 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 showing inaccurate values, which may result…
- Status
- Ongoing
- Distribution
- Worldwide Distibution: US (nationwide): OH, IL, CA, MI, FL, LA, OK, WA, AR, NJ, MN, MO, WI, MA, ND, NY, MD, OR, AK, NE, TN, AZ, IN, GA, GU, VA, PA, TX, SD, MT, NV, MS, KY, AL, CT, WV, KS, IA, NC, UT, CO, NH, DC, WY. OUS (foreign): ALBANIA, ARGENTINA…
- Enforcement report date
- June 14, 2023
- Risk class
- Class I (FDA's definition, 21 CFR 7.3(m): a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death)
- Status
- Ongoing (FDA has not recorded a termination for this recall; FDA's definition: a recall which is currently in progress; as in openFDA's data of Nov. 10, 2026)
- Filed by
- Medtronic Navigation, Inc.
- Product
- StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systems
- Reason
- 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 showing inaccurate values, which may result in prolonged/additional procedure, tissue injury
- Distribution pattern
- Worldwide Distibution: US (nationwide): OH, IL, CA, MI, FL, LA, OK, WA, AR, NJ, MN, MO, WI, MA, ND, NY, MD, OR, AK, NE, TN, AZ, IN, GA, GU, VA, PA, TX, SD, MT, NV, MS, KY, AL, CT, WV, KS, IA, NC, UT, CO, NH, DC, WY. OUS (foreign): ALBANIA, ARGENTINA, Australia, AUSTRIA, BANGLADESH, BARBADOS, BELGIUM, Bosnia and Herzegovina, BULGARIA, CANADA, CHILE, CROATIA, CZECH REPUBLIC, DENMARK, FRANCE, GREECE, INDIA, IRELAND, ITALY, JAPAN, LUXEMBOURG, MARTINIQUE, NEW ZEALAND, POLAND, PORTUGAL, Republic of Korea, ROMANIA, RUSSIAN FEDERATION, SINGAPORE, SLOVAKIA, SPAIN, SWITZERLAND, TAIWAN, Turkey, UNITED ARAB EMIRATES, UNITED KINGDOM
- Quantity
- 746
- Codes and lots
- Model/UDI-DI; Software Version: 9735585/00763000631635, 9735586/00763000631765, 9735587/00763000631826; 3.1.4
- Recall started
- April 11, 2023
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Neurological Stereotaxic Instrument
- Root cause (FDA)
- Software design
- What the company told customers
- On 4/11/23, correction notices were sent to healthcare professionals that were advised of the following; 1) Do not utilize the following: a) Biopsy Depth Gauge Graphic in Cranial Biopsy procedures. In accordance with the IFU: Frequently confirm navigation accuracy and system responsiveness during live navigation. Use the navigation instrument to touch several bony anatomical landmarks and confirm that the locations identified on the images match the locations touched on the patient. If accuracy degrades, re-register the patient. Always use the Biopsy Needle Mechanical Depth Stop. If system navigation seems inaccurate and steps to restore accuracy are unsuccessful, abort use of the system. b) Distance to/past Target value for Tumor Resection, Shunt Placement, and DBS procedures. Per the IFU: "Warning: Frequently confirm navigation accuracy and system responsiveness during live navigation. Use the navigation instrument to touch several bony anatomical landmarks and confirm that the locations identified on the images match the locations touched on the patient. If accuracy degrades, re-register the patient." and "If system navigation seems inaccurate and steps to restore accuracy are unsuccessful, abort use of the system." 2) All physician users should review the correction notice. Pass on the notice to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. Please maintain a copy of this notice in your records. 3) Complete and return the customer confirmation form that can be returned to neuro.quality@medtronic.com. Firm will provide warning and instructional placards to be applied to the affected systems. Firm is currently working on a software update and will communicate additional information when it becomes available. If you have any questions related to this issue, contact Technical Services for help at: 1-888-826-5603 or email at rs.navtechsupport@medtronic.com
- Recall number
- Z-1630-2023
What the record says about this device
A simplified drawing of a device, following the words of FDA's record. It shows the reason the record gives, not a photograph of the product.
“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 showing inaccurate values, which may result in prolonged/additional procedure, tissue injury”StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systems, FDA enforcement report, 2023-06-14. The caption is the record's own words.
A generic device, not the product. The mark follows the record's own words.
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FDA device name: Neurological Stereotaxic Instrument
Distributed in (FDA's record): Alabama Alaska Arizona Arkansas California Colorado Connecticut District of Columbia Florida Georgia Illinois Indiana Iowa Kansas Kentucky Louisiana Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania South Dakota Tennessee Texas Utah Virginia Washington West Virginia Wisconsin Wyoming and nationwide
This recall among the others
- FDA's enforcement report came 64 days after the firm started the recall. For half of the 835 FDA medical device recall events reported in 2023 with a start date, it took 51 days or fewer (by year).
- Medtronic Navigation: 7 other recalls or notices on this site in the three years before this one (from June 14, 2020).
Counted from the agency records on this site, as on Statistics: a recall event once, by its first notice.
What should I do? How serious is a recall? Classes and warnings explained · How to read this record
Source: FDA · Medical device enforcement report, recall number Z-1630-2023. See this record in openFDA (FDA's own data service; it answers in JSON). The agency record governs; check it and the company before acting.
Cite this record
FDA recall record Z-1630-2023, June 14, 2023. "StealthStation Cranial Software." PlainRecords, https://plainrecords.com/recall/device/z-1630-2023/ (as of the day it was built).At each build a sample of records from each source is compared with the agency's published file and the page; every correction is public. Drawings are chosen by software that reads the record. Built daily. How we check · Corrections