This page has been archived on the Web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.
System DI-60 Main Unit and Remote Review Software (2017-05-05)
- Starting date:
- May 5, 2017
- Posting date:
- June 7, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-63536
Affected Products
A. System Di-60 Main Unit
B. System Di-60 Remote Review Software
Reason
The DI-60 automated digital cell morphology analyzer shuts down the database and stops processing slides after 100 consecutive slides are run on one day. The following error message displays, "No connection with the database." This is a software defect and impacts only the DI-60 and DI-60 with system DI-60 remote review software.
Affected products
A. System Di-60 Main Unit
Lot or serial number
60060-60769 with 6.0.1SOFTWARE
Model or catalog number
CC286297
Companies
- Manufacturer
-
Sysmex Corporation
1-5-1 Wakinohama-kaigandori
Chuo-ku
651-0073
JAPAN
B. System Di-60 Remote Review Software
Lot or serial number
60060-60769 with 6.0.1SOFTWARE
Model or catalog number
BC188562
Companies
- Manufacturer
-
Sysmex Corporation
1-5-1 Wakinohama-kaigandori
Chuo-ku
651-0073
JAPAN