This page has been archived on the Web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.

Health product recall

RAPIDPOINT 500 SYSTEM (2015-07-29)

Starting date:
July 29, 2015
Posting date:
August 18, 2015
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-54686

Affected Products

A. RAPIDPOINT 500 SYSTEM

Reason

Siemens has issued an urgent field safety notice to inform customers of potential when both ports (Serial and Ethernet) are configured to transmit data, the data stream from one port could potentially affect the data stream from the other port. This could cause the message received by the LIS (Data Management System) to include either: duplicate data, missing data, data from a different patient. Siemens has not observed this scenario and the expected frequency of occurrence is extremely unlikely. If this issue occurs, only one analyte has the potential to be affected (i.e., if a panel of analytes is ordered, only one could be affected).

Affected products

A. RAPIDPOINT 500 SYSTEM

Lot or serial number

All

Model or catalog number

RAPIDPOINT 500

Companies
Manufacturer
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
New York
UNITED STATES