StealthStation S8 Surgical Navigation System Software Anomaly Recall
Medtronic is recalling StealthStation S8 and FlexENT systems with software versions 2.0 and 2.0.1 due to a software anomaly that could cause surgical planning data to shift to an unintended location.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification mandates a minimum severity score of 4. Although no reported deaths, injuries, or hospitalizations are stated, the hazard involves potential surgical planning data integrity issues that could impact surgical navigation accuracy during critical medical procedures.
Plain-English summary
Medtronic Navigation, Inc. is recalling StealthStation S8 systems running application software versions 2.0 and 2.0.1 (Part 9735762), as well as StealthStation FlexENT systems with the same software versions. The StealthStation S8 is used in neurosurgery to locate anatomical structures during open or percutaneous procedures. The StealthStation FlexENT is used in ENT procedures for the same purpose. Approximately 5,240 affected systems have been distributed worldwide.
The recall is due to a software anomaly that could potentially cause surgical planning data to shift to an unintended location. This anomaly could affect the accuracy of surgical navigation during procedures, potentially impacting surgical planning and guidance.
Affected systems are identified by Model Number 9735762 and UDI-DI Code 00763000532123. The systems have been distributed to all U.S. states, Puerto Rico, and over 40 countries worldwide. Healthcare facilities using these systems should contact Medtronic Navigation, Inc. immediately for instructions on software updates or system management.
The recalled product
- Product
- StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The StealthStation System, with StealthStation Cranial software, is intended as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures. The StealthStation FlexENT
- Manufacturer
- Medtronic Navigation, Inc.
- Hazard
- software-anomaly
- data-integrity
- navigation-error
Distribution
Distributed nationwide across the United States.
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