Zimmer Surgical Inc recalls A.T.S. 2200TS Tourniquet Systems, Personalized Pressure. Zimmer Surgical, Inc. Dover, OH 44622 Intended to be used

Recalled February 21, 2018 · FDA recall Z-0613-2018 · Zimmer Surgical

Hazard

Updated on-device label and 3 pages of an updated Operator/Service Manual. Also, decrease from 3.8 meters (m) to 1.0 separation distance between the device and RF communication equipment. · FDA Class II

Units

8,231 devices total

Sold at

Worldwide Distribution: US (nationwide) to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, including Guam; and countries to Australia, Brazil, Canada, Chile, China, Denmark, Dominican, El Salvador, England, Finland, France, Hong Kong, India, Italy, Japan, Malaysia, Mexico, Netherlands, Panama, Singapore, Sweden, Taiwan, and Thailand..

Description

Updated on-device label and 3 pages of an updated Operator/Service Manual. Also, decrease from 3.8 meters (m) to 1.0 separation distance between the device and RF communication equipment.

Product

A.T.S. 2200TS Tourniquet Systems, Personalized Pressure. Zimmer Surgical, Inc. Dover, OH 44622 Intended to be used by qualified professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities.

Manufacturer(s)

Zimmer Surgical Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →