Dimension EXL with LM, Dimension EXL 200, Dimension RxL… recallZ-1615-2015 · Siemens Healthcare Diagnostics, Inc. · initiated Apr 2, 2015
Class II Terminated All recalls posted in May 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Under Investigation by firm
What the company is doing
Siemens sent an Urgent Field Safety Notice, dated April 2015, was issued for distribution to affected customers in Japan to notify them of the issue. A Siemens Service Representative will visit customer sites to inspect the Dimension instrument power plug and wall outlet configuration. If the instrument is configured with a non-standard 15 Amp plug/outlet or a 20 Amp twist lock plug, Siemens will correct the issue identified, ensuring that the system is installed according to the instrument requirements.
Recall details
- Recall number
- Z-1615-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Apr 2, 2015
- Posted by the FDA
- May 14, 2015
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 17801
- Product code
- JJE
- FDA submissions
- K073604, K112999, K130276
- Distribution
- Distributed in the country of Japan.
Product description
Dimension EXL with LM, Dimension EXL 200, Dimension RxL, Dimension RxL HM, Dimension RxL Max, Dimension RxL Max HM, Dimension Xpand, Dimension Xpand HM, Dimension Xpand Plus, Dimension Xpand Plus HM. The Dimension EXL clinical chemistry system is a discrete, random-access, microprocessor-controlled, integrated instrument/chemistry system that measures a variety of analytes, including enzyme activities, in body fluids for in vitro diagnostic use.
Code information (models, lots, serial numbers)
Model numbers: D045912, D193440, D140066; Material Numbers: 10472176, 10636928, 10465412, 10461038, 10444828, 10444829, 10461849, 10461043, 10444837, 10444838
Other devices under the same FDA submission
2 devices cleared under K073604, K112999, K130276 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Dimension® EXL™ with LM Integrated Chemistry System 10472176Siemens Healthcare Diagnostics Inc. · ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE1 recall73 reports
- Dimension® QuikLYTE® Multisensor Na+/K+/Cl- 10445058Siemens Healthcare Diagnostics Inc. · ELECTRODE, ION-SPECIFIC, CHLORIDE34 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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