Pacific Medical Group Inc.: Medical Device Recall in 2020 - (Recall #: Z-0985-2020)

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:

Pacific Medical Philips M1356A Ultrasound Transducer with belt/wire knob, FFPH5250

Product Classification:

Class II

Date Initiated: September 19, 2019

Date Posted: February 12, 2020

Recall Number: Z-0985-2020

Event ID: 83869

Reason for Recall:

Fetal transducers distributed in advance of receiving 510(k) and international clearances.

Status: Ongoing

Product Quantity: 225

Code Information:

All serial numbers sold between 01/21/2015 - 04/30/2019

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated