Z-2707-2020 Class II Terminated
FDA device recall Z-2707-2020 was initiated by Medtronic Navigation, Inc. on June 5, 2020 and is designated Class II. Reason for recall: 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 tracker… The recall status is terminated (terminated May 28, 2024). Affected quantity: 2.
Recall Details
- Product Type
- Devices
- Report Date
- August 5, 2020
- Initiation Date
- June 5, 2020
- Termination Date
- May 28, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2
Product Description
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.
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution including in the states of Alabama and Massachusetts.
Code Information
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.