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Dimension Exl with Lm System

by Siemens Healthcare Diagnostics, Inc.

510(k) K130276

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

6 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK130276 Date22 Mar 2013ClearedStatusActive

Recalls

6 recalls · FDA

    • Terminated Z-0409-2019 FDA Class II initiated 28 Sep 2018

    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

  • 2 recalls, same reason

    • Terminated Z-0459-2016 FDA Class II initiated 10 Nov 2015
    • Terminated Z-0458-2016 FDA Class II initiated 10 Nov 2015

    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.

    • Terminated Z-1615-2015 FDA Class II initiated 2 Apr 2015

    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.

    • Terminated Z-2553-2014 FDA Class II initiated 16 Jul 2014

    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.

    • Terminated Z-2133-2014 FDA Class III initiated 27 May 2014

    There is a misassembly issue with the photometer installed on Dimension Integrated Chemistry Systems instruments. Through internal investigation by Siemens Healthcare Diagnostics has confirmed that a limited number of Dimension photometers were misassembled. These photometers are performing within specifications, but may lead to a shortened life of the source lamp.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JJE
Device Class
Class I
Regulation
21 CFR Part 862.2160
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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