Alinity C and I Processing Module (2018-02-22)
- Starting date:
- February 22, 2018
- Posting date:
- March 23, 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-66276
Affected products
A. ALINITY C PROCESSING MODULE
B. ALINITY I PROCESSING MODULE
Reason
During the installation of an Alinity ci-series System Control Module (SCM01163), the Field Service Engineer observed a sharp edge and burrs and scratched his hand on the sharp edge of a Processing Module Location Flag, RSM (Part # A-30105086-01). This part is contained in both Alinity i and c modules.
Affected products
A. ALINITY C PROCESSING MODULE
Lot or serial number
Ac01001 - Ac01025
Ac01027 - Ac01069
Ac01071 - Ac01100
Ac01102 - Ac01116
Ac01118 - Ac01129
Model or catalog number
03R67-01
Companies
- Manufacturer
-
Abbott GmbH and Co. K.G.
Max Planck Ring 2
Wiesbaden
65205
GERMANY
B. ALINITY I PROCESSING MODULE
Lot or serial number
Ai01001 - Ai01166
Ai01168 - Ai01172
Ai01176
Model or catalog number
03R65-01
Companies
- Manufacturer
-
Abbott GmbH and Co. K.G.
Max Planck Ring 2
Wiesbaden
65205
GERMANY