FDA Medical Device Recalls (openFDA)
GE Healthcare, LLC: GE Healthcare innova 3100-IQ, Mobile X-ray system The innova 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.
- Recall number
- Z-0114-2013
- Recalling firm
- GE Healthcare, LLC
- Product
- GE Healthcare innova 3100-IQ, Mobile X-ray system The innova 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.
- Status
- Terminated
- Initiated
- 2011-12-20
- Posted
- 2012-10-17
- Terminated
- 2013-09-18
- Reason
- It was discovered of a potential failure of the spectral filter mechanism inside the collimator of the innova 3100, innova 3100-IQ and innova 3131-IQ systems.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- GE Healthcare will, without charge, remedy the defect or bring the product into compliance with each applicable Federal standard in accordance with a plan to be approved by the Secretary of Health and Human Services. A GE Healthcare Service Representative will replace the collimator to address the issue. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. Further questions please call 262-513-4122.
- Quantity
- 199 installed in the US
- Distribution
- Nationwide distribution
- Lot, serial or model codes
- Model number - 5892935G052G
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IZI
- Firm FEI
- 2126677
- Firm city
- Waukesha
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28