Power F2 Powered Fastening System, Power F2, Item No. 0567093 used with Power X2 Stretche…
Official notice from a government agency or its published feed.
Power F2 Powered Fastening System, Power F2, Item No. 0567093 used with Power X2 Stretchers, Power X2, Item No. 0015816 and PowerX2 Premium, Item No. 0015821
Reason: Firmware issue may result in intermittent loss or degradation of powered functionality when paired with compatible stretcher. The issue may lead to the system not operating in powered mode, or exhibiting reduced powered performance. Issue may result in interruption or delay in patient transport.
Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · Worldwide - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, FL, ID, IL, KY, LA, ME, MN, MO, MT, NC, NE, NJ, NM, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, WV and the countries of Netherlands and Poland.
Reason: Firmware issue may result in intermittent loss or degradation of powered functionality when paired with compatible stretcher. The issue may lead to the system not operating in powered mode, or exhibiting reduced powered performance. Issue may result in interruption or delay in patient transport.
Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · Worldwide - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, FL, ID, IL, KY, LA, ME, MN, MO, MT, NC, NE, NJ, NM, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, WV and the countries of Netherlands and Poland.
Hazard: Firmware issue may result in intermittent loss or degradation of powered functionality when paired with compatible stretcher. The issue may lead to the system not operating in powered mode, or exhibi…
View the FDA enforcement report ↗ ← All reports