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Health product recall

DIMENSION ANALYZERS (2015-11-12)

Starting date:
November 12, 2015
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-56182

Affected Products

  1. DIMENSION RXL MAX W/HM ANALYZER
  2. DIMENSION EXL ANALYZER WITH LOCI MODULE
  3. DIMENSION EXL ANALYZER WITH LOCI MODULE
    1. Reason

      Siemens Healthcare Diagnostics Inc. is informing customers of a potential safety issue regarding the dimension reagent management system (RMS) refrigeration compressor. Siemens has identified RMS refrigeration compressors that are missing the safety cover on the electrical termination block. The exposed electrical hazard on the electrical termination block is located directly behind the RMS reagent waste container.

      Affected products

      A. DIMENSION RXL MAX W/HM ANALYZER

      Lot or serial number

      All lots.

      Model or catalog number

      752000.931-R

      Companies
      Manufacturer
      Siemens Healthcare Diagnostics Inc.
      500 GBC DRIVE, MAILSTOP 514, P.O. BOX 6101
      Newark, Delaware
      19714-6101
      UNITED STATES

      B. DIMENSION EXL ANALYZER WITH LOCI MODULE

      Lot or serial number

      All lots. 

      Model or catalog number

      778021.911

      Companies
      Manufacturer
      Siemens Healthcare Diagnostics Inc.
      500 GBC DRIVE, MAILSTOP 514, P.O. BOX 6101
      Newark, Delaware
      19714-6101
      UNITED STATES

      C. DIMENSION EXL ANALYZER WITH LOCI MODULE

      Lot or serial number

      All lots.

      Model or catalog number

      778021.911

      Companies
      Manufacturer
      Siemens Healthcare Diagnostics Inc.
      500 GBC DRIVE, MAILSTOP 514, P.O. BOX 6101
      Newark, Delaware
      19714-6101
      UNITED STATES