NM/CT 850 Model Number: H3907AD — Class II medical device recall Z-2991-2020
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 number | Z-2991-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2020-08-14 |
| Classified | 2020-09-21 |
| Reported by FDA | 2020-09-30 |
| Terminated | 2021-05-06 |
| Distributed | AR, 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 US | AR, 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 |
| Quantity | 25 units |
| Serial numbers | 850X61001, 850X61002, 850X61004, 850X61005, 85EX67001, 85EX67002, 85EX67003, 85EX67004, 85EX67005, 85EX67006, 85EX67007, 85EX67008, 85EX67009, 85EX67010, 85EX67011, 85EX67012, 85EX67013, 85EX67014, 85EX67016, 85EX67017, 85EX67018, 85EX67019, 85EX67021, 85EX67023, 85EY67015 |
| Model numbers | H3907AD |
Product
NM/CT 850 Model Number: H3907AD
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-2991-2020. 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.