ClearanceBrief
Recall Z-1161-2020 ยท HGL Transducer, Ultrasonic, Obstetric

Pacific Medical Group Inc.

Button-Style Ultrasound Transducer (Nautilus), 8-foot Cord 5700HAX, that may have been serviced with the following: Pacific Medical GE Corometrics Nautilus Ultrasound Board, NFCM9510; Pacific Medical GE Corometrics Nautilus Ultrasound Bottom Case, NFCM9515, Pacific Medical GE Corometrics Nautilus Ultrasound Cable Assembly, NFCM9520; Pacific Medical GE Corometrics Nautilus Ultrasound Crystal, NFCM9

DateSep 11, 2019
StatusOpen, Classified
ReasonFetal/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.
Root causeDevice Design
ActionOn 09/11/19, gent Medical Device Recall notices were emailed to customers. Customers were advised of the following possible failures associated with the post-market events: 1) Fluid damage/intrusion, solder cracks, component failure, 2) Damaged membrane or cracked case, 3) Internal short from usage, broken connector from misuse, 4) Broken leads, loose coil, 5) Loose crystal from failure of adhesive, internal short or improper grounding, 6) Miscalibration of the device/waveform, 7) Overheat of device. Malfunction of the device is likely to be recognized easily because the device will not funct
Quantity6481
DistributionWorldwide 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
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K012718MODIFICATION TO COROMETRICS MODEL 120IS MATERNAL/FETAL MONITORING SYSTEM.
Ge Medical Systems Information Technologies, Nov 13, 2001