Recall Z-0980-2020 ยท HFM Monitor, Uterine Contraction, External (For Use In Clinic)
Pacific Medical Group Inc.
Pacific Medical GE Corometrics Nautilus Toco Transducer w/wing (2264LAX), FFCM3260
| Date | Sep 19, 2019 |
| Status | Open, Classified |
| Reason | Fetal transducers distributed in advance of receiving 510(k) and international clearances. 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 interruption of monitoring due to device failure that could lead to delay in detecting maternal or fetal distress. |
| Root cause | No Marketing Application |
| Action | On 09/19/19, Urgent Medical Device Recall notices were emailed to customers informing them of the following possible failures associated with the post market events: - Fluid damage/intrusion, solder cracks, component failure. - Damaged membrane or cracked case. - Internal short from usage, broken connector from misuse. - Broken leads, loose coil. - Loose crystal from failure of adhesive, internal short or improper grounding. - Miscalibration of the device/waveform. - Overheat of device. Malfunction of the device is likely to be recognized easily because the device will not function properly |
| Quantity | 628 |
| Distribution | U.S.: IN, AZ, IL, HI, AK, AR, CA, FL, GA, IA, ID, LA, MA, NC, NE, NM, NY, OK, PA, TN, TX, UT, VA, WA, WV, NV, KY, CO, ME, ND, OH, SC, WI, AL, OR, DC, DE, MD, MI, MN, MO, MT, MS, NJ, NH. O.U.S. (Foreign): CA, CO, FR, GB, IT, MX, UAE |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012718 | MODIFICATION TO COROMETRICS MODEL 120IS MATERNAL/FETAL MONITORING SYSTEM. Ge Medical Systems Information Technologies, Nov 13, 2001 |