Recall Z-0982-2020 ยท HGM System, Monitoring, Perinatal
Pacific Medical Group Inc.
Pacific Medical GE Corometrics Nautilus Ultrasound, 5700 (Old Style), FFCM5660
| Date | Sep 19, 2019 |
| Status | Open, Classified |
| Reason | Fetal transducers distributed in advance of receiving 510(k) and international clearances. |
| 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 | 4 |
| 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 |