Ultrasound Transducer (M1356A), that may have been serviced with the following: Pacific Medical Philips M1356A Ultrasound Board, NFPH9510; Pacific Medical Philips M1356A Ultrasound Bottom Case, NFPH9515; Pacific Medical Philips M1356A Ultrasound Cable Assembly, NFPH9520; Pacific Medical Philips M1356A Ultrasound M1356A Crystal, NFPH9535

Reason: 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.

Code information: All serial numbers serviced between 12/18/14 and 4/2/19.

Distribution pattern: 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.