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Health product recall

Dimension Systems Analyzers (2015-11-12)

Starting date:
November 12, 2015
Posting date:
February 1, 2016
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-56880

Affected Products

  1. DIMENSION CLINICAL CHEMISTRY SYSTEM-RXL MAX ANALYZER
  2. DIMENSION RXL MAX ANALYZER
  3. DIMENSION CHEMISTRY SYSTEM-DIMENTION RXL MAX W/HM ANALYZER
  4. DIMENSION EXL SYSTEM - DIMENSION EXL ANALYZER WITH LOCI MODULE
  5. DIMENSION EXL SYSTEM - DIMENSION EXL ANALYZER WITH LM

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

  1. DIMENSION CLINICAL CHEMISTRY SYSTEM-RXL MAX ANALYZER

Lot or serial number

ALL

Model or catalog number
  • 752000.901
Companies
Manufacturer
Siemens Healthcare Diagnostics Inc.
500 GBC DRIVE, MAILSTOP 514, P.O. BOX 6101
Newark
19714-6101
Alabama
UNITED STATES

B. DIMENSION RXL MAX ANALYZER

Lot or serial number

ALL

Model or catalog number

752000.901

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

C. DIMENSION CHEMISTRY SYSTEM-DIMENTION RXL MAX W/HM ANALYZER

Lot or serial number

ALL

Model or catalog number

752000.911
752000.931-R
752000.941

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

D. DIMENSION EXL SYSTEM - DIMENSION EXL ANALYZER WITH LOCI MODULE

Lot or serial number

ALL

Model or catalog number

778021.911

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

E. DIMENSION EXL SYSTEM - DIMENSION EXL ANALYZER WITH LM

Lot or serial number

ALL

Model or catalog number

778021.911

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