FDA Device recall Z-2992-2020
NM/CT 860, SPECT/CT
- FDA Device
- Class II
- terminated
- Published 2020-09-30
On 2020-09-30 the FDA classified a Class II recall of NM/CT 860, SPECT/CT by Ge Healthcare, citing rotor bearing screws were found loose on detector.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2992-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-08-14 |
| Published | 2020-09-30 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ge Healthcare |
| Distribution | 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 |
Product
NM/CT 860, SPECT/CT
Reason
Rotor bearing screws were found loose on detector.
Identifiers
| code_info | Serial # 850X61003 , System ID: 401793860NM, Model # H3908AD Serial # 860X62001 , System ID:E6843969, Model # H3908AE…Serial # 850X61003 , System ID: 401793860NM, Model # H3908AD Serial # 860X62001 , System ID:E6843969, Model # H3908AE Serial # 870X64005 , System ID:HC4387NU05, Model # H3100AS Serial # 860X62002 , System ID:PL0399NM01, Model # H3100AS |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2992-2020%22
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