FDAFDA · Food and drugs·Recall number Z-2707-2020
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.
Published August 5, 2020 · Recall initiated: June 5, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
There is a potential for specific camera units to be affected by a characterization issue during manufacturing that results in inaccurate navigation while utilizing both the active and passive trackers simultaneously. While no injuries or illnesses have been reported, If impacted cameras were to be used with both active and passive trackers simultaneously, it would result in system navigation inaccuracy of 6mm.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Medtronic Navigation, Inc.
- Distributor
- US Nationwide distribution including in the states of Alabama and Massachusetts.
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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