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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