FDA Medical Device Recalls (openFDA)
GE Healthcare: GE Healthcare Optima CL 323i. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
- Recall number
- Z-1985-2015
- Recalling firm
- GE Healthcare
- Product
- GE Healthcare Optima CL 323i. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
- Status
- Terminated
- Initiated
- 2015-05-29
- Posted
- 2015-07-03
- Terminated
- 2015-10-28
- Reason
- GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery).
- Root cause
- Nonconforming Material/Component
- Action
- The firm, GE Healthcare, sent an "Urgent Medical Device Correction" letter on 5/29/2015- GEHC Ref#12231- dated May 29, 2015 to their Consignees. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction, and contact Information. The customers were instructed that you may continue to use the system and avoid rapid direction changes with the gantry motions and prevent potential collisions with other equipment. If the failure occurs during interventional examination, please ensure that you have established procedures for handling patients in case of the loss of gantry motion as stated in your product labeling. GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for this correction. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
- Quantity
- 7
- Distribution
- Worldwide Distribution: US (nationwide) including states of: CA, DE, FL, GA, IL, IN, KS, MS, NV, OH, OK, OR, PA, TN, TX, VA, WA and WI; and countries of: ARGENTINA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, FRANCE, GERMANY, HONG KONG, HUNGARY, INDIA, INDONESIA, ITALY, JAPAN, RUSSIA, UNITED KINGDOM, and VIETNAM.
- Lot, serial or model codes
- Serial Number System ID Not Available GON4271838 Not Available 229890CL Not Available 361788CL323 Not Available 806358INNOVA 0C2V069A4104R1 082416310033 0C2V069A4202R1 082416200021 0C2V069A4203R1 082416050013
- 510(k) numbers
- ["K122457"]
- 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