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FDA (Device enforcement)Recalled 2018-08-14closedclass ii

Siemens Healthcare Diagnostics, Inc.: STREAMLAB - REFRIGERATED STORAGE MODULE 15000

Is my product affected?

STREAMLAB - REFRIGERATED STORAGE MODULE 15000

  • UPC 00630414949765

Check against the official notice below — it lists the full affected range.

What happened

Siemens Healthcare Diagnostics, Inc. is recalling 186 StreamLAB Refrigerated Storage Module 15000 units because they may have been shipped without a warning label alerting users to the potential risk of interference with pacemaker functionality. The affected products were distributed across 38 U.S. states and multiple foreign countries including Australia, Canada, France, Germany, India, Italy, and others. The recalled modules are identified by Siemens Material Numbers 10482428 and UDI 00630414949765.

The recall notice does not specify a remedy or corrective action for consumers who have received these modules.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

Reason for recall: The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality. Distribution: 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, L Quantity: 186 StreamLAB Automation Modules Lot/code info: Siemens Material Numbers: 10482428; UDI: 00630414949765

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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