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
- Spencer probe electrodes
- Standard strip
- T-shaped strip
- Asymmetrical strip
- Dual-sided strip
- Standard grid
- Asymmetrical grid
- Pre-defined grid
- Subdural electrode - standard strip
- Subdural electrode - t-shaped strip
- Subdural electrode - asymmetrical strip
- Subdural electrode - dual-sided strip
- Subdural electrodes - standard grid
- Subdural electrodes -asymmetrical grid
- Subdural electrodes - irregular grid
- Subdural electrodes - dual-sided grid
- Placement kit anchor bolts
- 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
-
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