FDA Device recall Z-2376-2012
GE Healthcare, Innova 2121IQ, Innova 3131IQ Cardiovascular X-ray imaging systems
- FDA Device
- Class II
- terminated
- Published 2012-09-19
On 2012-09-19 the FDA classified a Class II recall of GE Healthcare, Innova 2121IQ, Innova 3131IQ Cardiovascular X-ray imaging systems by Ge Healthcare, citing GE Healthcare has recently become aware of a potential safety issue with respect to the Innova 2121IQ & Innova 3131IQ Systems. While performing a fluoroscopic acquisition with the….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2376-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-08-16 |
| Published | 2012-09-19 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | AL, AZ, CA, CO, CT, FL, HI, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, NH, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV |
Product
GE Healthcare, Innova 2121IQ, Innova 3131IQ Cardiovascular X-ray imaging systems. K060259: The Innova 3131IQ (3131-IQ) and 2121 IQ (2121-IQ) biplane systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational angiography procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. These devices are not intended for mammography applications. K061163: For Innova 2121IQ, Innova 3131IQ, Innova 4100, Innova 4100IQ, Innova 3100, Innova 3100IQ, Innova 2100IQ devices with Innova IVUS option: The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. Those devices are not intended for mammography applications. Innova IVUS Option: The Innova IVUS software option simplifies the clinical workflow associated with the use of Volcano IVUS products by: (1) automatically synchronizing the patient demographic information (patient name, date of birth, DICOM attributes etc.) from Innova system with an IVUS imaging system, (2) providing a remote access to commonly used IVUS functions from the Innova table side user interface, (3) displaying the IVUS images on the multi-monitor display of the Innova cathlab system. K091658: The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. These devices are not intended for mammography applications.
Reason
GE Healthcare has recently become aware of a potential safety issue with respect to the Innova 2121IQ & Innova 3131IQ Systems. While performing a fluoroscopic acquisition with the Innova 2121IQ or Innova 3131IQ systems, there is a potential for loss of usable imaging mode which requires the system to restart in order to recover.
Identifiers
| code_info | System ID (As required) 910162015 AZ4001VA01 BH1000VA01 BY4033VA01 BY4020VA02 BG4549VA01 BG4009VA01 416480INNOV…System ID (As required) 910162015 AZ4001VA01 BH1000VA01 BY4033VA01 BY4020VA02 BG4549VA01 BG4009VA01 416480INNOVA2 HSRINNOVA1 82416070010 82416150007 82416210022 82416040046 CS1006VA05 EG1000VA01 M4198064 N4192939 M4166990 M4212443 HC1819XR10 HC5284XR39 542120XR02 HC5284XR38 83016862100448 835160028 IQ1165VA02 IE1100VA03 A5632421 A5102694 A5379605 A5320145 B5114298 A5360408 YV0370 YV0365 YV0364 YV0166 YV0369 YV0473 YV0480 YV0478 YV0475 YV0362 YV0510 YV0474 YV0481 YV0367 YV0477 YV0388 YV0466 YV0500 YV0463 YV0476 YV0464 YV0462 YV0400 YV0366 YV0501 YV0520 YV0363 YV0555 YV0472 YV0471 YV0470 YV0469 YV0468 YV0467 KW1098VA01 KW1098VA02 KW1011VA02 LB1331VA01 LY1086VA01 834160006 834160005 834160004 INNOVA2948687 PL1804VA01 PER18124 RO1095VA01 RU3427VA01 RU2741VA04 RU3847VA01 RU3883VA01 NA SA2253VA01 SA2236VA01 847160005 847160006 850060744 850060739 MEX68922 853060209 853060201 853060200 853060198 85 |
|---|
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-2376-2012%22
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