Health product recall

Spencer Probe electrodes, Standard. T-shaped, Asymmetrical, and Dual-sided strips, Standard, Asymetrical, and Pre-defined grids, Subdural electrode - standard, T-shaped, asymmetrical, and dual-sided strips, Subdural electrodes - standard, asymmetrica...

Starting date:
June 10, 2019
Posting date:
July 3, 2019
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-70335

Last updated: 2019-07-03

Affected Products

  1. Spencer probe electrodes
  2. Standard strip
  3. T-shaped strip
  4. Asymmetrical strip
  5. Dual-sided strip
  6. Standard grid
  7. Asymmetrical grid
  8. Pre-defined grid
  9. Subdural electrode - standard strip
  10. Subdural electrode - t-shaped strip
  11. Subdural electrode - asymmetrical strip
  12. Subdural electrode - dual-sided strip
  13. Subdural electrodes - standard grid
  14. Subdural electrodes -asymmetrical grid
  15. Subdural electrodes - irregular grid
  16. Subdural electrodes - dual-sided grid
  17. Placement kit anchor bolts
  18. Platinum foramen ovale electrodes

Reason

MRI information for subdural electrodes, depth electrodes, and anchor bolts was sent to customers upon request. Subdural electrodes, depth electrodes, and anchor bolts have not been evaluated for safety and compatibility in the MR environment. They have not been tested for heating, migration, or image artifact in the MR environment. The safety of the electrodes in the MR environment is unknown.

Affected products

  1. Spencer probe electrodes

Lot or serial number

Not applicable.

Model or catalog number

All models. 

Companies
Manufacturer

Ad-Tech Medical Instrument Corp.

400 WEST OAKVIEW PARKWAY

OAK CREEK

Wisconsin

UNITED STATES

B. Standard strip

Lot or serial number

Not applicable.

Model or catalog number

All models.

Companies
Manufacturer

Ad-Tech Medical Instrument Corp.

400 WEST OAKVIEW PARKWAY

OAK CREEK

Wisconsin

UNITED STATES

C. T-shaped strip

Lot or serial number

Not applicable.

Model or catalog number

All models.

Companies
Manufacturer

Ad-Tech Medical Instrument Corp.

400 WEST OAKVIEW PARKWAY

OAK CREEK

Wisconsin

UNITED STATES

D. Asymmetrical strip

Lot or serial number

Not applicable.

Model or catalog number

All models.

Companies
Manufacturer

Ad-Tech Medical Instrument Corp.

400 WEST OAKVIEW PARKWAY

OAK CREEK

Wisconsin

UNITED STATES

E. Dual-sided strip

Lot or serial number

Not applicable.

Model or catalog number

All models.

Companies
Manufacturer

Ad-Tech Medical Instrument Corp.

400 WEST OAKVIEW PARKWAY

OAK CREEK

Wisconsin

UNITED STATES

F. Standard grid

Lot or serial number

Not applicable.

Model or catalog number

All models.

Companies
Manufacturer

Ad-Tech Medical Instrument Corp.

400 WEST OAKVIEW PARKWAY

OAK CREEK

Wisconsin

UNITED STATES

G. Asymmetrical grid

Lot or serial number

Not applicable.

Model or catalog number

All models.

Companies
Manufacturer

Ad-Tech Medical Instrument Corp.

400 WEST OAKVIEW PARKWAY

OAK CREEK

Wisconsin

UNITED STATES

H. Pre-defined grid

Lot or serial number

Not applicable.

Model or catalog number

All models.

Companies
Manufacturer

Ad-Tech Medical Instrument Corp.

400 WEST OAKVIEW PARKWAY

OAK CREEK

Wisconsin

UNITED STATES

I. Subdural electrode - standard strip

Lot or serial number

Not applicable.

Model or catalog number

All models.

Companies
Manufacturer

Ad-Tech Medical Instrument Corp.

400 WEST OAKVIEW PARKWAY

OAK CREEK

Wisconsin

UNITED STATES

J. Subdural electrode - t-shaped strip

Lot or serial number

Not applicable.

Model or catalog number

All models.

Companies
Manufacturer

Ad-Tech Medical Instrument Corp.

400 WEST OAKVIEW PARKWAY

OAK CREEK

Wisconsin

UNITED STATES

K. Subdural electrode - asymmetrical strip

Lot or serial number

Not applicable.

Model or catalog number

All models.

Companies
Manufacturer

Ad-Tech Medical Instrument Corp.

400 WEST OAKVIEW PARKWAY

OAK CREEK

Wisconsin

UNITED STATES

L. Subdural electrode - dual-sided strip

Lot or serial number

Not applicable.

Model or catalog number

All models.

Companies
Manufacturer

Ad-Tech Medical Instrument Corp.

400 WEST OAKVIEW PARKWAY

OAK CREEK

Wisconsin

UNITED STATES

M. Subdural electrodes - standard grid

Lot or serial number

Not applicable.

Model or catalog number

All models.

Companies
Manufacturer

Ad-Tech Medical Instrument Corp.

400 WEST OAKVIEW PARKWAY

OAK CREEK

Wisconsin

UNITED STATES

N. Subdural electrodes -asymmetrical grid

Lot or serial number

Not applicable.

Model or catalog number

All models.

Companies
Manufacturer

Ad-Tech Medical Instrument Corp.

400 WEST OAKVIEW PARKWAY

OAK CREEK

Wisconsin

UNITED STATES

O. Subdural electrodes - irregular grid

Lot or serial number

Not applicable.

Model or catalog number

All models.

Companies
Manufacturer

Ad-Tech Medical Instrument Corp.

400 WEST OAKVIEW PARKWAY

OAK CREEK

Wisconsin

UNITED STATES

P. Subdural electrodes - dual-sided grid

Lot or serial number

Not applicable.

Model or catalog number

All models.

Companies
Manufacturer

Ad-Tech Medical Instrument Corp.

400 WEST OAKVIEW PARKWAY

OAK CREEK

Wisconsin

UNITED STATES

Q. Placement kit anchor bolts

Lot or serial number

Not applicable.

Model or catalog number

All models.

Companies
Manufacturer

Ad-Tech Medical Instrument Corp.

400 WEST OAKVIEW PARKWAY

OAK CREEK

Wisconsin

UNITED STATES

R. Platinum foramen ovale electrodes

Lot or serial number

Not applicable.

Model or catalog number

All models.

Companies
Manufacturer

Ad-Tech Medical Instrument Corp.

400 WEST OAKVIEW PARKWAY

OAK CREEK

Wisconsin

UNITED STATES