MAVIG Portegra or Portegra2 Overhead Counterpoise System (2018-12-11)
- Starting date:
- December 11, 2018
- Posting date:
- January 23, 2019
- 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-68884
Affected products
MAVIG Portegra or Portegra2 Overhead Counterpoise System
Reason
If the overhead counterpoise system head mount knob is not properly tightened and the operator directly uses the injector head to move the unit, it may become disengaged, causing the injector head to become loose or fall.
Affected products
MAVIG Portegra or Portegra2 Overhead Counterpoise System
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
- EOA 700
- EOC 700
- EOC 700S
- EOW 700
- OCS 115A
- OCS 115AS
- OCS 115CT
- OCS 115CTS
- OCS 125A
- OCS 125CT
- OCS 135A
- OCS 135CT
- OCS 145
- OCS 155A
- OCS 165A
- OCS CEIL 100-P
- OCS CEIL 100-S
- OCS CEIL 58-P
- OCS CEIL 58-S
- OCS CEIL 70SI
- OCS CEIL 85-P
- OCS CEIL 85-S
- OCS CEIL 97SI
- OCS TRACK 58-P
- OCS TRACK 58-S
- OCS TRACK 80-P
- OCS TRACK 80-S
- OCS WALL P
- OCS WALL S
Companies
- Manufacturer
-
Bayer Medical Care Inc.
1 Bayer Drive
Indianola
15051-0780
Pennsylvania
UNITED STATES