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Terminated

STREAMLAB - REFRIGERATED STORAGE MODULE 9000

FDA Recall Z-0216-2019 · Posted None

Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeLXG
Date Initiated2018-08-14
Date Terminated2020-09-04
Product Quantity186 StreamLAB Automation Modules

Reason for Recall

The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.

Firm Action

Urgent Medical Device Correction notification letters dated 8/14/18 were distributed to customers.

Root Cause

Under Investigation by firm

Distribution Pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, SC, TN, TX, VA, WA, and WV. The products were distributed to the following foreign countries: Australia, Austria, Bangladesh, Belgium, Canada, Croatia, France, Germany, Greece, Hong Kong, India, Indonesia, Italy, Libya, Netherlands, Philippines, Portugal, Saudi Arabia, Slovakia, Slovenia, Spain, Taiwan, Thaliand, UAE, UK.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K082638ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELLSiemens Healthcare Diagnostics, Inc. · 2009-02-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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