FDA-Device2020-12-09Class II
BladderScan Prime Plus Probe REF 0570-0395 - Product Usage: intended to be used for measuring the urine volume in the bladder noninvasively.
Verathon, Inc.
Hazard
Due to a change in handle material and process, probe handle may crack.
Sold states
Worldwide distribution - U.S. Nationwide distribution including in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WI, WV and WY. The countries of Austrailia, Belgium, Canada, France, Germany, Kuwait, Luxembourg, New Zealand, Portugal, Singapore, Sweden, Switzerland, Taiwan, and United Kingdom.
Affected count
398 units
Manufactured in
20001 N Creek Pkwy, N/A, Bothell, WA, United States
Products
BladderScan Prime Plus Probe REF 0570-0395 - Product Usage: intended to be used for measuring the urine volume in the bladder noninvasively.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0531-2021Don't want to check this manually?
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