Z-1160-2020 Class II Ongoing
FDA device recall Z-1160-2020 was initiated by Pacific Medical Group Inc. on September 11, 2019 and is designated Class II. Reason for recall: 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: inabi… The recall status is ongoing. Affected quantity: 10911.
Recall Details
- Product Type
- Devices
- Report Date
- February 19, 2020
- Initiation Date
- September 11, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10911
Product Description
Loop-Style Tocotransducer (Nautilus) 2264LAX, that may have been serviced with the following: Pacific Medical GE Corometrics Nautilus Toco Board, NFCM9310; Pacific Medical GE Corometrics Nautilus TOCO Bottom Case, NFCM9315; Pacific Medical GE Corometrics Nautilus TOCO Cable Assembly, NFCM9320; Pacific Medical GE Corometrics Nautilus TOCO Coil with Screws, NFCM9325
Reason for Recall
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.
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.
Code Information
All serial numbers serviced between 1/19/15 and 4/2/19