Device Recall Subdural Electrode

  • Model / Serial
    REF numbers (catalog numbers):  EG10A-SP10N-000, EG34B-SP10X-000, EGD7A-MP12N-000, EGE4A-SP10N-000, EGE4A-SP10X-000, QG10B-SP10X-000, QG10C-SP10N-000, QG10D-SP10N-000, QG11A-SP10X-000, QG16A-SP10X-000, QG17A-SP10X-000, QG18A-SP10N-000, QG18A-SP10X-000, QG20B-SP10N-000, QG20B-SP10X-000, QG20C-SP10N-000, QG20C-SP10X-000, QG20D-SP10X-200, QG20E-SP10X-000, QG20F-SP10X-000, QG24A-SP10N-000, QG26A-SP10N-000, QG32A-SP10X-000, QG32B-SP10X-000, QG36A-SP10N-000, QG36A-SP10X-000, QG36B-SP10N-000, QG44A-SP10X-000, QG53A-SP10X-000, QG66A-SP85N-000, QG69A-SP10N-000, QG88A-SP10X-000, QG96A-SP10N-000, QG96A-SP10X-000, QG96C-SP10X-000, QG96D-SP10X-000, QGC6A-SP07N-000, QGC8A-SP10N-000, QGC8A-SP10X-000, QGC8B-SP10X-000, QGC8C-SP10X-000, QGC8D-SP10N-000, QGC8E-SP10X-000, QGC8F-SP10X-000, QS20A-SP10N-000, QS40B-SP10X-000,   Lot numbers: 208140314, 208140343, 208140344, 208140353, 208140354, 208140362, 208140369, 208140374, 208140381, 208140382, 208140387, 208140390, 208140395, 208140398, 208140399, 208140414, 208140417, 208140421, 208140431, 208140443, 208140445, 208140450, 208140452, 208140453, 208140458, 019020, 208140356R, 208140357R, 208140452R, C010180001, C702201001, C703160006, C704040001, C800250002, C800350004, C801240003, C802220003, C802220005, C802220006, C805210003, C805210004, C908221002, G012111001, G012140002, G015020002, G016240001, G017250004, G017250005, G017250006, G018011001, G018011002, G018011003, G019021002, G019021003, G019150003, G112270004, G114160001, G114160002, G115080002, G115170004, G115280005, G119020004, G211220001, G608060002, G704150001, G805270001, G900211002, G903011001, G903080003, S903080004, S905280003.  Recall exanded on 5/2/2013 to include additional Macro Micro Subdural Electrodes: REF numbers (catalog numbers):  CG-64BPX-F436, CMMS-22PX-F478 CG-32BPX-F412, CGIE-98BPX-F341, CGIE-82BPN-F377, CMMS-69PN-F480, CGIE-98BPN-F341, CG-9SN-F496, CG-32BPX-F426, CG-16BPX-F445, CG-16BPX-F446, CG-256PX-F425, CGIE-39BPX-F442, CG-46BPX-F465, CG-64BPX-F419, CG-32BPX-F418.  Lot numbers:  20814044, 208140447, 208140463, 208140463, 208140476, 208140463, 08140463, 208140424, 208140439, G119221001,G212040002, G216040002, 218190,  208140431, 208140450, 208140432, 208140433, 208140420, 208140437,  208140450, 208140422, 208140422, 208140422, 208140422
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide including the states of CA, GA, LA, MA, MD, MI, MN, NH, PA, RI, TX, UT, WI, NY IA, WI and the countries of: Australia, CANADA, ENGLAND, JAPAN, KOREA, SPAIN, FRANCE, and SWITZERLAND.
  • Product Description
    Ad-Tech Medical Instrument Corporation Macro Micro Subdural Electrode. For temporary (<30 days) use with recording, monitoring and stimulation equipment, for the recording, monitoring and stimulation of electrical signals on the surface level of the brain. The recording of electrical activity supports definition of the location of epileptogenic foci and brain mapping.
  • Manufacturer
  • 1 Event

Manufacturer