Health product recall

HistoCore PELORIS 3 (2018-05-16)

Starting date:
May 16, 2018
Posting date:
June 1, 2018
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-66926

Affected products

HistoCore PELORIS 3

Reason

If operator initiates an operation in second retort or the protocol running concurrently in second retort causes a dialog box to appear when draining first retort at completion of protocol, a software defect may interrupt instrument workflow sequences in the first retort resulting in the impeller continuing to rotate.

Affected products

HistoCore PELORIS 3

Lot or serial number

45110009
45110028
45110033
45110036

Model or catalog number

45.0005

Companies
Manufacturer

Leica Biosystems Melbourne Pty. Ltd.

495 Blackburn Road

Mount Waverley, Victoria

3149

AUSTRALIA