FDA-Device2024-01-03Class III

Liberty Select Cycler, Model numbers RTLR180343 and RTLR180111

Hazard

Affected Liberty Select cyclers may display an incorrect time stamp on the treatment data report sent to the clinic.

Sold states
US Nationwide distribution in the states of AL, CA, FL, IL, IN, LA, MI, MO, MT, NC, NJ, NV, OH, OK, OR, PA, SC, TN, TX, VA.
Affected count
149 US
Manufactured in
920 Winter St Bld 920, Waltham, MA, United States
Products
Liberty Select Cycler, Model numbers RTLR180343 and RTLR180111

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0619-2024

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