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Zimmer, Inc. recalls ATS 3000 Automatic Tourniquet System w/HOSES AND LOP SENSOR Intended to be used by qualified medical professionals
Recalled November 21, 2012 · FDA recall Z-0296-2013 · Zimmer
Hazard
Zimmer is conducting a voluntary removal of some Zimmer A.T.S. 3000 tourniquets after receiving complaints of both out-of-box failures and failures during surgical procedures on some of the affected units. During failure the unit will alarm, lock into a non-operational mode, and the display screen will go blank. Based on investigation, this problem appears to be due to a counterfeit chip on the · FDA Class II
Units
204
Sold at
Worldwide Distribution - USA (nationwide) and Internationally to Belgium, Czech Republic, Egypt, France, Germany, Morocco, Netherlands, Romania, Saudi Arabia, Spain, Switzerland, Turkey, and UAE.
Description
Zimmer is conducting a voluntary removal of some Zimmer A.T.S. 3000 tourniquets after receiving complaints of both out-of-box failures and failures during surgical procedures on some of the affected units. During failure the unit will alarm, lock into a non-operational mode, and the display screen will go blank. Based on investigation, this problem appears to be due to a counterfeit chip on the
Product
ATS 3000 Automatic Tourniquet System w/HOSES AND LOP SENSOR Intended to be used by qualified medical professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities.
Manufacturer(s)
Zimmer, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →