GE Optima CT520 and Optima CT540 Computed Tomography (CT) systems. Intended to produce cross-sectional images of the bod
FDA device recall Z-0840-2014 · posted 2014-01-27 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- There is an issue with the Manual Film Composer feature on some CT products. There is an opportunity, while following a specific workflow, to create a film image with one patient's images and another patient's name in the footer. This is also an issue when within Manual Film Composer, if a color image is selected for printing, another patient's black and white image appears in the preview screen
- Action taken
- Consignees were sent on 10/9/2013 a GE Healthcare "Urgent Medical Device Correction" letter dated October 9, 2013. The letter was addressed to Hospital Administrators / Risk Managers, Radiology Directors and Radiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information (Contact your local GE Healthcare Service Representative or the GE Healthcare Call Center : US or Canada : 800-437-1171 and Other countries: 262-896-2890).
- Root cause
- Software design
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 272 (29 US; 243 OUS)
- Distribution
- Worldwide Distribution-USA (nationwide) including the states of AL, CO, FL, IN, KS, KY, MN, NC, OH, TX, and VA, and the countries of ALGERIA, AUSTRALIA, BELGIUM, BULGARIA, CANADA, CHINA, ABIDJAN COTED
- Date initiated
- 2013-10-09
- Date posted
- 2014-01-27
- Date terminated
- 2014-06-19
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OPTIMA CT520 (K123596) | Ge Hangwei Medical Systems Co., Ltd. | 2013-02-08 |
| GE BRIGHTSPEED DELIGHT CT SCANNER SYSTEM (K082816) | Ge Medical Systems, LLC | 2008-10-08 |