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StealthStation Cranial Software recallZ-1776-2024 · Medtronic Navigation, Inc. · initiated Mar 26, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medtronic Navigation, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 navigation.

FDA root cause category: Software design

What the company is doing

On April 10, 2024, Medtronic Navigations, Inc. issued an Urgent: Medical Device Correction to affected consignees via UPS. In addition to informing consignees about the issue, Medtronic asked consignees to take the following actions: 1. Please review this information with all physician users. If you have any questions related to this issue, please contact Medtronic Technical Services for help at 1-888-826-5603 or email at [email protected]. 2. Please confirm via the enclosed confirmation form that this notification has been communicated within your facility with all physician users. Send the completed Customer Confirmation Form to Medtronic via email at [email protected]. a. Medtronic will work expeditiously with your facility to coordinate a software update at no charge to resolve this anomaly. 3. Pass this notice on to 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. 4. Adverse reactions or quality problems experienced with this product should be reported to FDA and Medtronic. Online at http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm (form available to fax or mail). Call FDA at (800) FDA-1088. Call Medtronic Technical Services at 1-888-826-5603.

Recall details

Recall number
Z-1776-2024
Status
Open, Classified
Initiated by the company
Mar 26, 2024
Posted by the FDA
May 9, 2024
Recalling firm
Medtronic Navigation, Inc.
Quantity
3286 applications.
Product code
HAW
FDA submissions
K162309
Distribution
Worldwide distribution. US nationwide including Puerto Rico, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt, El Salvador, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Iran, Ireland, Israel, Italy, Japan, Kazakhstan, Kenya, Republic Of Korea, Kuwait, Latvia, Lebanon, Libya, Lithuania, Malaysia, Martinique, Mexico, Morocco, Netherlands, Nicaragua, Norway, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and Vietnam.

Product description

Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures.

Code information (models, lots, serial numbers)

UDIs: 00763000234867, 00763000125295, 00763000063177, 00643169865341/ Software Versions: 1.2.0, 1.1.0, 1.0.3, 1.0.2, and 1.0.1.

Devices named in this recall

4 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

25 devices cleared under K162309 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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