Medtronic StealthStation S7 System Recalled for Navigation Inaccuracy
Medtronic is recalling two StealthStation S7 Systems with Polaris Spectra Cameras due to a manufacturing issue that may cause 6mm navigation inaccuracy when using specific trackers.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (Score 3).
Plain-English summary
Medtronic Navigation, Inc. is recalling two StealthStation S7 Systems equipped with Polaris Spectra Cameras. The recall affects specific camera units that may have a characterization issue from manufacturing. This issue can result in inaccurate navigation if the system is used with both active and passive trackers simultaneously.
The potential hazard is a system navigation inaccuracy of 6mm. The source text states that no injuries or illnesses have been reported. The affected units are distributed nationwide in the United States, including in Alabama and Massachusetts.
The specific units involved are StealthStation S7 Serial Number N06164844 with Polaris Spectra Camera Serial Number P7-01896, and StealthStation S7 Serial Number N07308697 with Polaris Spectra Camera Serial Number P7-18852. Users should contact Medtronic Navigation for further instructions on how to proceed with the recall.
The recalled product
- Product
- StealthStation" S7 System with Polaris Spectra Camera part number PSU 9733437 - Product Usage: are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures.
- Manufacturer
- Medtronic Navigation, Inc.
- Hazard
- Affected units
- 2
Distribution
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