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Reagent Management System (RMS) recallZ-0459-2016 · Siemens Healthcare Diagnostics Inc. · initiated Nov 10, 2015

Class II Terminated All recalls posted in December 2015

Is my device affected?

  1. 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.
  2. 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.
  3. 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

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.

FDA root cause category: Nonconforming Material/Component

What the company is doing

Siemens sent an Urgent Medical Device Correction (UMDC # DI-16-01.A.US) and Urgent Field Safety Notice (UFSN # DI-16-01.A.OUS) letters dated November 2015 to all affected customers. The letters identified the affected product, problem and actions to be taken. For questions contact your local Siemens technical support representative.

Recall details

Recall number
Z-0459-2016
Recall class
Class II
Status
Terminated
Initiated by the company
Nov 10, 2015
Posted by the FDA
Dec 22, 2015
Recalling firm
Siemens Healthcare Diagnostics Inc.
Quantity
4
Product code
JJE
FDA submissions
K130276
Distribution
US Nationwide Distribution: FL, NY, SC, TX, LA, AZ, WI, IA, IL, OH, AL, AK, NH, OK, MD, CA, NM, MS, KY, NJ, MN, GA, CO, MA, SD, TN, MO, PA, MT, SC, NE, KS, VA, AL, NV, WY, OR, PR, MO, OK, GU, HI, AR, ME, VT, CT, NC and the countries of Canada and Mexico.

Product description

Reagent Management System (RMS) Dimension EXL with LM STM Product Usage: The Reagent Management System (RMS) is a module for use with the Dimension clinical chemistry system. The RMS doubles the available storage of refrigerated Flex reagent cartridges on the Dimension system from 44 to 88. The RMS loads, hydrates, and automatically removes Flex reagent cartridges, allowing the Dimension system to process samples without interruption.

Code information (models, lots, serial numbers)

Dimension EXL with LM STM Catalog Numbers 778031.911 (Domestic) /778031.931 (Intl). All serial numbers.

Other devices under the same FDA submission

1 device cleared under 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.

Other products in the same recall event

The FDA groups related products into one recall event (event 72738).

Sources and updates

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