Data Foundry

Medical device recalls 2020

NM 830 Model # H3910AC — Class II medical device recall Z-2995-2020

Terminated recall by GE Healthcare, LLC, reported 2020-09-30, distributed in AR, CT, FL, GA, IL, KS, KY, LA…. Rotor bearing screws were found loose on detector.

Recall numberZ-2995-2020
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmGE Healthcare, LLC, Waukesha, WI, United States
Recall initiated2020-08-14
Classified2020-09-21
Reported by FDA2020-09-30
Terminated2021-05-06
DistributedAR, CT, FL, GA, IL, KS, KY, LA, MA, MD, MI, MN, MO, NE, NJ, NV, NY, OH, OK, RI, SC, TN, TX, VA, VT, WA, WI
Countries outside the USAR, AT, BE, BR, CA, CH, CN, DE, ES, FR, GB, GR, IL, IN, IT, JP, KR, NL, NO, PA, PL, PT, RU, SE, TH, TR, TW, VN
Quantity25 units
Serial numbers830X60001, 830X60002, 830X60003, 830X60004, 830X60005, 830X60006, 830X60007, 830X60008, 830X60009, 830X60010, 830X60011, 830X60012, 830X60013, 830X60014, 830X60015, 830X60016, 830X60017, 830X60018, 830X60019, 830X60020, 830X60021, 830X60022, 830X60023, 830X60024, 830X60025
Model numbersH3910AC

Product

NM 830 Model # H3910AC

Reason for recall

Rotor bearing screws were found loose on detector.

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-2995-2020. 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.