ORTHO VISION (2019-07-16)
- Starting date:
- July 16, 2019
- Posting date:
- July 26, 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-70537
Last updated: 2019-07-26
Affected Products
- ORTHO VISION Analyzer
- ORTHO VISION Max Analyzer
Reason
Due to a software anomaly on ORTHO VISION and ORTHO VISION Max Analyzers configured with software version 5.12.3 or 5.12.4, flushing of the Pipette may occur in an unexpected location after the Pipette arm (PIPA) exits IDLE mode and moves away from the Wash Station while refilling the Liquid System (LSYS) with saline.
Affected products
A. ORTHO VISION Analyzer
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
6904577
Companies
- Manufacturer
-
ORTHO-CLINICAL DIAGNOSTICS INC.
1001 US HWY 202
Raritan
08869
New Jersey
UNITED STATES
B. ORTHO VISION Max Analyzer
Lot or serial number
70002012
70002013
70002021
70002022
70002027
Model or catalog number
6904576
Companies
- Manufacturer
-
ORTHO-CLINICAL DIAGNOSTICS INC.
1001 US HWY 202
Raritan
08869
New Jersey
UNITED STATES