FDA Device recall Z-0453-2015
Innova 4100IQ Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and Interventional…
- FDA Device
- Class II
- terminated
- Published 2014-12-24
On 2014-12-24 the FDA classified a Class II recall of Innova 4100IQ Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and Interventional… by Ge Healthcare, citing loss of imaging - affected devices may experience a loss of real-time interventional imaging and/or gantry motion due to the Electromagnetic (EM) sensitivity of the grid detection….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0453-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-09-04 |
| Published | 2014-12-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | CA, CO, FL, MO, PA |
Product
Innova 4100IQ Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and Interventional procedures and optionally, rotational imaging procedure.
Reason
Loss of imaging - affected devices may experience a loss of real-time interventional imaging and/or gantry motion due to the Electromagnetic (EM) sensitivity of the grid detection mechanism.
Identifiers
| code_info | Mfg Lot or Serial # System ID 00000583668BU9 610983INNOVA3 00000643314BU8 082406090024 00000644609BU0 082406210011…Mfg Lot or Serial # System ID 00000583668BU9 610983INNOVA3 00000643314BU8 082406090024 00000644609BU0 082406210011 00000645290BU8 082406110006 00000645780BU8 082406040032 00000648200BU4 082406070014 |
|---|
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-0453-2015%22
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