Pacific Medical Group Inc.: Medical Device Recall in 2020 - (Recall #: Z-1163-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

External Toco Transducer (M1355A), that may have been serviced with the following: Pacific Medical Philips M1355A Toco Bottom Case, NFPH9315; Pacific Medical Philips M1355A Toco Cable Assembly, NFPH9320; Pacific Medical Philips M1355A Toco Gauge, NFPH9340

Product Classification:

Class II

Date Initiated: September 11, 2019

Date Posted: February 19, 2020

Recall Number: Z-1163-2020

Event ID: 83610

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.

Status: Ongoing

Product Quantity: 1603

Code Information:

All serial numbers serviced between 10/20/14 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.

Voluntary or Mandated:

Voluntary: Firm initiated