FDA Device recall Z-0966-2015
GE Healthcare, Discovery IGS 730 & Discovery IGS 740
- FDA Device
- Class II
- terminated
- Published 2015-01-21
On 2015-01-21 the FDA classified a Class II recall of GE Healthcare, Discovery IGS 730 & Discovery IGS 740 by Ge Healthcare, citing potential unintentional system motion or rotation due to a positioning user interface issue with Discovery IGS 730 and 740 products.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0966-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-12-10 |
| Published | 2015-01-21 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | CO, CT, MS, NJ, NY, OH, WA |
Product
GE Healthcare, Discovery IGS 730 & Discovery IGS 740. Discovery IGS 730 : The angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular & non vascular diagnostic and interventional procedures. Discovery IGS 740: The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and nonvascular, diagnostic and interventional procedures.
Reason
Potential unintentional system motion or rotation due to a positioning user interface issue with Discovery IGS 730 and 740 products.
Identifiers
| code_info | Mfg Lot or Serial # System ID 0000013C2A0001 203694IGS730 0000011C2A0005 610954OR1 0000014A2A0009 718283D740 000001…Mfg Lot or Serial # System ID 0000013C2A0001 203694IGS730 0000011C2A0005 610954OR1 0000014A2A0009 718283D740 0000014A2A0007 SO4208228 0000014A2A0016 SO4242294 0000014A2A0004 206VMDISCOVERY1 Not available 330375HOR 0000014A2A0006 190020RX26 Not available 190059RX30 Not available SO4165355 Not available 82416120043 Not available 82416040061 00000011C2A003 A4185526 0000012C2A0002 M4160476 0000014A2A0008 S41600101 00000612802BU9 M54866AG1 Not available M40480222 Not available HC4348XR11 0000014A2A0001 YV2000 Not available XR649425BU6 Not available SO4239583 Not available AE1477RX04 0000013A2A0003 00169VAS01 0000013A2A0002 10692VAS01 |
|---|
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-0966-2015%22
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