CLASS II Device recall · Reported 5 Aug 2020 · FDA Enforcement Report
StealthStation" S7 System with Polaris Spectra Camera recalled
Medtronic Navigation is recalling StealthStation" S7 System with Polaris Spectra Camera, distributed nationwide in the US. The recall was initiated on 5 Jun 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2707-2020
- FDA event ID
- 85901
- Recalling firm
- Medtronic Navigation, Louisville, CO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Jun 2020
- FDA classified
- 27 Jul 2020
- Reported
- 5 Aug 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Labeling Errors
- Device type
- Other Medical Devices
Timeline
| 5 Jun 2020 | Recall initiated by company | |
| 27 Jul 2020 | Classified by FDA | +52 days |
| 5 Aug 2020 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide distribution including in the states of Alabama and Massachusetts.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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.
Where was it sold?
US Nationwide distribution including in the states of Alabama and Massachusetts.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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