FDA Device recall Z-2387-2018
Innova IGS 630/520/530/540 Interventional Fluoroscopic X-ray Systems
- FDA Device
- Class II
- terminated
- Published 2018-07-18
On 2018-07-18 the FDA classified a Class II recall of Innova IGS 630/520/530/540 Interventional Fluoroscopic X-ray Systems by Ge Medical Systems Scs, citing the Discovery IGS and Innova IGS systems may experience X-ray abort errors which could result in the loss of imaging mode before or during fluoroscopic use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2387-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-03-29 |
| Published | 2018-07-18 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ge Medical Systems Scs |
| Distribution | AR, CA, FL, GA, IA, IL, NC, NH, NJ, NM, NY, PA, SC, TN, WI, WV |
Product
Innova IGS 630/520/530/540 Interventional Fluoroscopic X-ray Systems
Reason
The Discovery IGS and Innova IGS systems may experience X-ray abort errors which could result in the loss of imaging mode before or during fluoroscopic use.
Identifiers
| code_info | a. Innova IGS 630, Model Number 5730860 - Lot Number (System ID): 00000B3-18-001 (401BIPLANE1), 00000B3-17-032 (505841…a. Innova IGS 630, Model Number 5730860 - Lot Number (System ID): 00000B3-18-001 (401BIPLANE1), 00000B3-17-032 (505841CATH3), 00000B3-17-029 (956632IGS630), 00000B3-17-030 (YV4502), 00000B3-18-002 (941629IGS630), 00000B3-17-031 (082416160071), 00000B3-18-003 (GON 4601349); b. Innova IGS 520, Model Number 5731194 - Lot Number (System ID): 00000M2-18-008 (410337CATH3), 00000M2-17-090 (603663DIGS), 00000M2-17-088 (603433IGS520), 00000M2-18-004 (423493CATH1), 00000M2-18-002 (414649IGS5), 00000M2-18-003 (414649IGS6), 00000M2-17-087 (M2505310), 00000M2-18-009 (00197VAS02), 00000M2-17-091 (082416040075), 00000M2-18-012 (GON 4607591), 00000M2-18-007 (GON 4607578), 00000M2-18-010 (GON 4607585), 00000M2-18-018 (GON 4592554), 00000M2-17-089 (083016866794118), 00000M2-18-001 (083016865380618), 00000M2-18-005 (GON 4608047), 00000M2-18-019 (GON 4596530), 00000M2-18-013 (GON 4610633), 00000M2-17-092 (A5187111), 00000M2-18-015 (FEG51905), 00000M2-18-006 (GON 4588912); c. Innova IGS 530, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2387-2018%22
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