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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
- DIMENSION CLINICAL CHEMISTRY SYSTEM-RXL MAX ANALYZER
- DIMENSION RXL MAX ANALYZER
- DIMENSION CHEMISTRY SYSTEM-DIMENTION RXL MAX W/HM ANALYZER
- DIMENSION EXL SYSTEM - DIMENSION EXL ANALYZER WITH LOCI MODULE
- 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
-
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