SIEMENS HEALTHCARE DIAGNOSTICS INC
DIMENSION EXL · Chemistry
510(k) Clearances (3)
Substantially Equivalent
Substantially Equivalent
Substantially Equivalent
Recalls (6)
Thermal chamber motors have electrical cables with single insulation rather than the required double insulation. There is no exposed current due to the single insulation that could result in a potential electrical shock
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 Waste Container.
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 Waste Container.
Certain Dimension Integrated Chemistry Systems Instrument Power Configurations may have been installed with a non-standard instrument power plug.The use of a non-standard plug configuration as described may lead to a potential electrical hazard. The likelihood of potential clinical impact or injury due to this issue is extremely low.
The Reagent Lid hinge may lose its effectiveness and slowly shift downward during maintenance procedures, potentially resulting in physical contact and injury to the operator.
A rare variant of TSH, identified in a small cluster of patients, is not detected.
UDI Registrations (3)
LOCI High-Sensitivity Troponin I (TNIH)
LOCI High-Sensitivity Troponin Calibrator
Dimension® EXL with LM integrated chemistry system and Sample Transfer Module
MAUDE Adverse Events (10)
FDA Classification (67)
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
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Clinical Chemistry
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Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry