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Recall Observatory FDA recall evidence

Device product

Siemens StreamLAB(R) Analytical Workcell; Catalog number 746002.901. Designed to automate sample handling and processing in the clinical laboratory.

Z-1867-2014

October 11, 2012

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc.
Event
Event 63486
Status
Terminated
Classification
Class II
Quantity
317
Official record key
device-enforcement:Z-1867-2014

Official wording

Reason: Firm has received reports from customers that the small pins at the bottom of the center door panel of the Input/Output Module, which protrude approximately 5/8 inch (16 mm), have contributed to trip and fall incidents. Customers are advised that when working in the area of the Input/Output Module to be aware of the two pins that protrude and use caution.

Code information: All serial numbers

Distribution pattern: Nationwide Distribution -- AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Firm has received reports from customers that the small pins at the bottom of the center door panel of the Input/Output Module, which protrude approximately 5/8 inch (16 mm), have contributed to trip and fall incidents. Customers are advised that when working in the area of the Input/Output Module to be aware of the two pins that protrude and use caution.