This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
Permobil Powered Wheelchair (2017-08-18)
- Starting date:
- August 18, 2017
- Posting date:
- September 26, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Healthcare Professionals, General Public, Hospitals
- Identification number:
- RA-64554
Affected Products
Permobil Powered Wheelchair
Reason
This correction decision has been made because of a potential failure of the top plate, which is the component that connects the seating system of the wheelchair to the base. A complete failure of the top plate assembly would result in the chair user and the seating system falling from the base leading to a potential injury. Out of 71 cases reported to the FDA, 3 serious injuries occurred (2 broken bones/1 laceration).
Affected products
Permobil Powered Wheelchair
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- C300 BASE ONLY
- C300 CORPUS II
- C350 CORPUS II
- C400 CORPUS II
- C400 CORPUS II LR
- C500 BASE ONLY
- C500 CORPUS II
- C500 CORPUS II LR
Companies
- Manufacturer
-
PERMOBIL INC
300 DUKE DRIVE
LEBANON
37090
Tennessee
UNITED STATES