Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported October 16, 2024
StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spine software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures.
Due to two software anomalies that can occur within a spine procedure. Two issues are: 1. Navigation Orientation - when lateral orientation radiographic images are taken, inform…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Medtronic Navigation, Inc. recalled StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation S… - a moderate-severity action.
StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation S… was recalled by Medtronic Navigation, Inc. in October 16, 2024. Reason: Due to two software anomalies that can occur within a spine procedure. Two issues are: 1. Navigation Orient…. Check the official notice for the remedy. Verify recall #Z-0050-2025 with the FDA Devices before acting.
The recall
Medtronic Navigation, Inc. issued this moderate-severity FDA Devices recall-Due to two software anomalies that can occur within a spine procedure. Two issues are: 1. Navigation Orient….
- Moderate
- severity level
- Class II
- classification
- October 16, 2024
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0050-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0050-2025) was formally reported on October 16, 2024, with the manufacturer initiating the action on August 22, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. Medtronic Navigation, Inc. is listed as the recalling firm, operating out of Lafayette, CO. Federal records list the affected scope as 1,801 systems.
The documented reason for this recall is: Due to two software anomalies that can occur within a spine procedure. Two issues are: 1. Navigation Orientation - when lateral orientation radiographic images are taken, information may appear flipped when utilizing … Distribution data in the federal record shows the product reached: Worldwide - U.S Nationwide distribution including in the states of AK, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NM, NV, NY, OH, OK, PA, Puerto Rico, SC, TN, TX, UT, VA, WA,…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
1,801 systems
Related Recalls
6
3 from same agency
Product description
StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spine software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures.
Reason for recall
Due to two software anomalies that can occur within a spine procedure. Two issues are: 1. Navigation Orientation - when lateral orientation radiographic images are taken, information may appear flipped when utilizing the system (180 degree flipped). 2. Pop-up Message - when using CT+Fluouroscopy images with a slice spacing thickness greater than 2mm, the system does not display a pop-up message indicating the slice spacing is not optimal.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0050-2025 |
| Date reported | October 16, 2024 |
| Date initiated | August 22, 2024 |
| Recalling firm | Medtronic Navigation, Inc. |
| Firm location | Lafayette, CO |
| Affected scope | 1,801 systems |
| Distribution | Worldwide - U.S Nationwide distribution including in the states of AK, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NM, NV, NY, OH, OK, PA, Puerto Rico, SC, TN, TX, UT, VA, WA, WI and WV. The coun… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0050-2025) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spine software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures.. Recalled by Medtronic Navigation, Inc.. Units affected: 1,801 systems.
Why was this product recalled? ▼
Due to two software anomalies that can occur within a spine procedure. Two issues are: 1. Navigation Orientation - when lateral orientation radiographic images are taken, information may appear flipped when utilizing the system (180 degree flipped). 2. Pop-up Message - when using CT+Fluouroscopy images with a slice spacing thickness greater than 2mm, the system does not display a pop-up message indicating the slice spacing is not optimal.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 16, 2024. Severity: Moderate. Recall number: Z-0050-2025.
Where was the recalled product distributed? ▼
Distribution: Worldwide - U.S Nationwide distribution including in the states of AK, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NM, NV, NY, OH, OK, PA, Puerto Rico, SC, TN, TX, UT, VA, WA, WI and WV. The countries of Argentina, AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BELGIUM, Brazil, BULGARIA, CANADA, CHILE, China, Colombia, Costa Rica, CROATIA, CYPRUS, DENMARK, EGYPT, EL SALVADOR, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE, HUNGARY, ICELAND, India, ISRAEL, ITALY, Japan, Jordan, KAZAKHSTAN, KENYA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, Malaysia, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NICARAGUA, OMAN, PAKISTAN, PANAMA, Philippines, POLAND, PUERTO RICO, QATAR, Republic of Korea, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SERBIA, Singapore, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, Turkey, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0050-2025) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported October 16, 2024. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.