Pacific Medical Philips M1356A Ultrasound Transducer with belt/wire… — Class II medical device recall Z-0985-2020
Ongoing recall by Pacific Medical Group Inc., reported 2020-02-12, distributed in AK, AL, AR, AZ, CA, CO, DC, DE…. Fetal transducers distributed in advance of receiving 510(k) and international clearances.
| Recall number | Z-0985-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pacific Medical Group Inc., San Clemente, CA, United States |
| Recall initiated | 2019-09-19 |
| Classified | 2020-02-04 |
| Reported by FDA | 2020-02-12 |
| Distributed | AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV |
| Countries outside the US | AE |
| Quantity | 225 |
Product
Pacific Medical Philips M1356A Ultrasound Transducer with belt/wire knob, FFPH5250
Reason for recall
Fetal transducers distributed in advance of receiving 510(k) and international clearances.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0985-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.