FDA Device recall Z-1976-2015
GE Healthcare Innova 2100IQ. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnost…
- FDA Device
- Class II
- terminated
- Published 2015-07-08
On 2015-07-08 the FDA classified a Class II recall of GE Healthcare Innova 2100IQ. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnost… by Ge Healthcare, citing GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (I….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1976-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-05-29 |
| Published | 2015-07-08 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
GE Healthcare Innova 2100IQ. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
Reason
GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery).
Identifiers
| code_info | Serial Number System ID 00000465837BU3 610776INNOVA21 00000007C20214 760940INNOVA2 00000008C20031 083…Serial Number System ID 00000465837BU3 610776INNOVA21 00000007C20214 760940INNOVA2 00000008C20031 083016842102488 00000007C20126 083016242100487 00000459677BU1 00888VAS02 0000011C2M0208 727869EP4 0000009C2M0034 083016608167379 0000009C2M0022 083016202100349 Not Available 0835160049 0000012C2S0028 A5403911 00000464565BU1 M2844529 0000011BC20026 2192632121 FMI12181DUMM17 082416270004 00000466838BU0 082416160007 |
|---|
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-1976-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.