Day

December 28, 2018
28
Dec

Recall – Synergy Cranial and Stealth Station S7 Cranial Software Displayed Inaccuracies During Surgical Procedures, Class I

December 28, 2018
Company: Medtronic Navigation, Inc. Date of Enforcement Report: 12/29/2018 Class I: PRODUCT StealthStation Cranial and Synergy Cranial Depth Gauge: StealthStation Cranial Optical Pocket Guide – Instructions for cranial procedures using optical localization StealthStation Cranial version 3.0, 3.1 CE 0344 Rx Only 2018-02 9735489 Revision 3 Medtronic Navigation, Inc. Biopsy Needle Kit (9733068) Note: This device is...
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