FDA Device recall Z-1201-2019
Innova IGS 6, Interventional Fluoroscopic X-Ray System used in generating fluoroscopic and rotational images of human anatomy for cardiovas…
- FDA Device
- Class II
- ongoing
- Published 2019-04-24
On 2019-04-24 the FDA classified a Class II recall of Innova IGS 6, Interventional Fluoroscopic X-Ray System used in generating fluoroscopic and rotational images of human anatomy for cardiovas… by Ge Healthcare, citing there is a potential for loss of the x-ray imaging function when the user changes field of view (FOV) from 30cm to 20cm or from 20cm to 30cm while releasing the fluoroscopy footsw….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1201-2019 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-03-15 |
| Published | 2019-04-24 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
Innova IGS 6, Interventional Fluoroscopic X-Ray System used in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.
Reason
There is a potential for loss of the x-ray imaging function when the user changes field of view (FOV) from 30cm to 20cm or from 20cm to 30cm while releasing the fluoroscopy footswitch pedal simultaneously.
Identifiers
| code_info | Model Number 5771387; System ID (Serial Number, UDI Number): 501257IGS630 (B3-18-014, 01008406821246141118070021B…Model Number 5771387; System ID (Serial Number, UDI Number): 501257IGS630 (B3-18-014, 01008406821246141118070021B3-18-014); 951486RU630 (B3-18-009, 01008406821246141118040021B3-18-009); 714993IGS630 (B3-18-004, 01008406821246141118020021B3-18-004); 906225EP1 (B3-18-015, 01008406821246141118070021B3-18-015); 906225CATH4 (B3-18-016, 01008406821246141118080021B3-18-016); 843797IGS30 (B3-18-030, 01008406821246141119010021B3-18-030); 4603984XV41 (B3-18-019, 01008406821246141118090021B3-18-019); MCARIGS630 (B3-18-008, 01008406821246141118040021B3-18-008); 509473RM1B (B3-18-028, 01008406821246141119010021B3-18-028); 414649IGS8 (B3-18-020, 01008406821246141118090021B3-18-020); HU1099VA07 (B3-18-024, 01008406821246141118110021B3-18-024); A670060221 (B3-19-002, 01008406821246141119020021B3-19-002); A5163326 (B3-18-007, 01008406821246141118030021B3-18-007); YV4504 (B3-18-018, 01008406821246141118090021B3-18-018); YV4505 (B3-18-027, 01008406821246141118120021B3-18-027); YV4507 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1201-2019%22
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