CFPM300, CFPM301, CFPM400 and CFPM401 - Integrated Headrest, CFUR301, CFUR401 - Urology Table and CFLU401 Lithotripsy-Urology (2017-12-08)
- Starting date:
- December 8, 2017
- Posting date:
- January 12, 2018
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-65642
Affected products
- CFPM300-Integrated Headrest
- CFPM301-Integrated Headrest
- CFPM400 Integrated Headrest
- CFPM401-Integrated Headrest
- CFPMB301 Rectangular Top
- CFUR301 - Urology Table
- CFUR401 - Urology Table
- CFLU401 Lithotripsy-Urology
Reason
The recall is being initiated in response to issues with the foot control getting lodged under the base or column potentially resulting in unintended motion.
Affected products
A. CFPM300-Integrated Headrest
Lot or serial number
- FL30RT2426802PTTZZH65C
- FL30RT242680MGTTZZF6
Model or catalog number
CFPM300
Companies
- Manufacturer
-
Oakworks Medical Inc.
923 E Wellspring Rd
New Freedom
17349
Pennsylvania
UNITED STATES
B. CFPM301-Integrated Headrest
Lot or serial number
FL31IF222584MGTTZZF6
Model or catalog number
CFPM301
Companies
- Manufacturer
-
Oakworks Medical Inc.
923 E Wellspring Rd
New Freedom
17349
Pennsylvania
UNITED STATES
C. CFPM400 Integrated Headrest
Lot or serial number
- FL40IF222684MGTTZZF8
- FL40IF222684MGTTZZF85C
Model or catalog number
CFPM400
Companies
- Manufacturer
-
Oakworks Medical Inc.
923 E Wellspring Rd
New Freedom
17349
Pennsylvania
UNITED STATES
D. CFPM401-Integrated Headrest
Lot or serial number
Not applicable
Model or catalog number
CFPM401
Companies
- Manufacturer
-
Oakworks Medical Inc.
923 E Wellspring Rd
New Freedom
17349
Pennsylvania
UNITED STATES
E. CFPMB301 Rectangular Top
Lot or serial number
Not applicable
Model or catalog number
CFPMB301
Companies
- Manufacturer
-
Oakworks Medical Inc.
923 E Wellspring Rd
New Freedom
17349
Pennsylvania
UNITED STATES
F. CFUR301 - Urology Table
Lot or serial number
Not applicable
Model or catalog number
CFUR301
Companies
- Manufacturer
-
Oakworks Medical Inc.
923 E Wellspring Rd
New Freedom
17349
Pennsylvania
UNITED STATES
G. CFUR401 - Urology Table
Lot or serial number
Not applicable
Model or catalog number
CFUR401
Companies
- Manufacturer
-
Oakworks Medical Inc.
923 E Wellspring Rd
New Freedom
17349
Pennsylvania
UNITED STATES
H. CFLU401 Lithotripsy-Urology
Lot or serial number
Not applicable
Model or catalog number
CFLU401
Companies
- Manufacturer
-
Oakworks Medical Inc.
923 E Wellspring Rd
New Freedom
17349
Pennsylvania
UNITED STATES