FDA-Device2020-02-19Class II
Toco MP Transducer (M2734B), that may have been serviced with the following: Pacific Medical Philips M2734B Avalon Smart TOCO Bottom Case, NFPHA9315-B
Pacific Medical Group Inc.
Hazard
Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. Possible adverse clinical impact: inability to accurately detect and measure fetal heart rate, inability to accurately detect maternal peripheral oxygen saturation, inability to monitor uterine activity to follow contractions, inability to determine temperature, and maternal blood pressure, lack of electrocardiography tracing, patient/clinician burns, and delay in detecting maternal or fetal distress.
Sold states
Worldwide Distribution - US Nationwide in the states of::NH, NY, MN, PA, FL, AZ, LA, GA, IL, HI, CA, OR, SC, OH, NC, IA, OK, AL, MA, MD, WI, MI, AR, WA, SD, NV, KY, TX, MS, DE, NJ, NE, WV, MT, TN, VA, MO, VT, CO, CT, ME, WY, IN, UT, NM, AK, DC, ID, KS, ND, RI, NH. OUS: BEL, ARE, MEX, CAN, CYM, KOR, ZAF, BHR, ESP, ITA, FRA, VUT, AUS, GBR.
Affected count
1776
Manufactured in
212 Avenida Fabricante, San Clemente, CA, United States
Products
Toco MP Transducer (M2734B), that may have been serviced with the following: Pacific Medical Philips M2734B Avalon Smart TOCO Bottom Case, NFPHA9315-B
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1168-2020Don't want to check this manually?
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