XS and XT Hematology Analyzers (2016-11-18)

Starting date:

November 18, 2016

Posting date:

December 5, 2016

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-61304

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  Reason
• 
  Affected products

Affected Products

A. XS-1000i, Hematology Analyzer

B. XT-2000i Hematology Analyzer

C. XN-10 Module

D. XN-11 Module

Reason

Sysmex America, Inc. (SAI) has become aware through customer complaints that the computer power supply on the information processing unit (IPU) used with the Sysmex XN-Series, XT-Series, and XS-Series hematology analyzers shut down, disabling the analyzer. The power supply has an over-voltage regulator to halt power in the presence of a power spike and prevent potential damage to the power supply and the associated device. The regulator in the power supplies within specific serial number range were found to be more sensitive than necessary to normal power fluctuations, causing the shutdown of the IPU during normal operation.

Affected products