FDA Device recall Z-0186-2015
Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system
- FDA Device
- Class II
- terminated
- Published 2014-11-19
On 2014-11-19 the FDA classified a Class II recall of Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system by Ge Healthcare, citing GE is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the c….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0186-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-10-14 |
| Published | 2014-11-19 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system. Models H3100NA, H3100PP, H3100RA, H2401LS, H2401LZ, H2402LS. Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy.
Reason
GE is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to the gantry. GE is updating the Preventative Maintenance procedure and schedule, and added an additional Preventative Maintenance check for loose fasteners on the Nuclear Medicaine systems.
Identifiers
| code_info | 21111 DUKECCDSV670NM 21189 DUKEDMP670NM 21223 307362D670 21224 660890D670 21079 0910267022 00000000103BH2 09102632…21111 DUKECCDSV670NM 21189 DUKEDMP670NM 21223 307362D670 21224 660890D670 21079 0910267022 00000000103BH2 0910263259 00000000124BH8 83092327843 00000000129BH7 83092719500 00000087514HL6 83092962829 00000097761HL1 83095572382 00000333837HM3 83091096402 21215 100039NU02 21229 210002NU11 21220 BY4033NM01 21166 82426070031 21213 82426040052 21222 082426040053 21231 082426070034 21230 082426080022 21226 TP0007NU02 21155 IE1018MN03 092302HL9 KW1001NM01 092303HL7 KW1112NM04 092307HL8 KW1112NM03 21148 ZWL0630 00000093649HL2 QA1064NM01 21173 RU2581NM01 21190 RU7174NM01 00000290644HM4 RU1493NM01 00000322039HM9 SA1006NM01 095718HL3 SA2315NM01 21219 0847260029 21218 M001NU43 21177 475260NU01 21234 00242NUC06 SAN00200 00258NUC02 21023 309671SPECT 21030 856247NM 21032 617638DSV670 21044 404686NMCT 21045 972935D670 21062 305674D670 21065 PITT670 21069 212639NMD670 21074 423495D670 21078 615322NM5 21105 803751D670 21114 614NCH670 21127 410D6701 21149 54 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0186-2015%22
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