Z-3052-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 30, 2017
- Initiation Date
- June 29, 2017
- Termination Date
- August 3, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 149 instruments
Product Description
Medtronic Curved Suction 70 9733450 EM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The suction devices are part of a family of reusable ENT instruments that are used with the StealthStationTM AxiEM surgical navigation system. The AxiEM system is an electromagnetic (EM) tracking solution for surgical tools. The system measures an induced voltage created by local magnetic fields from a set of coils in the transmit coil array (TCA). Each surgical tool has a set of receiving coils to sense the magnetic field strength. Using a mathematical algorithm, the position and orientation of the instrument can be computed and overlaid/registered to imagery on a computer monitor, resulting in the ability to track the instrument tip in relation to the patients anatomy. AxiEM ENT Suction devices are used as suction and pointing devices. The suction devices are intended to have an ENT Instrument Tracker mounted on it
Reason for Recall
The instruments are not able to pass instrument verification which is performed prior to the use of each instrument.
Distribution Pattern
Worldwide Distribution - US (nationwide) and Internationally to Canada.
Code Information
Lot numbers 17030722, 17022421,17022020, 17020619, 17011918, 17012417, I 17010602, 16122724,16122239, 16122038, 16120563, and 16112362