FDA Medical Device Recalls (openFDA)
GE Healthcare, LLC: GE SENOGRAPHE DS FULL FIELD MAMMOGRAPHY SYSTEM MAMMOGRAPHIC FILM / SCREEN SYSTEM
- Recall number
- Z-1044-2011
- Recalling firm
- GE Healthcare, LLC
- Product
- GE SENOGRAPHE DS FULL FIELD MAMMOGRAPHY SYSTEM MAMMOGRAPHIC FILM / SCREEN SYSTEM
- Status
- Terminated
- Initiated
- 2010-07-20
- Posted
- 2011-03-17
- Terminated
- 2012-05-16
- Reason
- It was noticed that 3 units received in Japan were missing the rating plate on the X-ray tube cover. There is a potential that other X-ray tube covers are missing the rating plate.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- An Important Electronic Product Radiation Warning letter was issued to customers identifying the affected product and describing the defect along with the related hazards. The letter states that there are no actions that are required to be taken on the part of the customer. A GE Healthcare Service Representative will apply the missing rating as necessary and free of charge. Questions or concerns regarding the letter should be directed to 1-800-437-1171 in the US.
- Quantity
- 112 total
- Distribution
- Worldwide Distribution
- Lot, serial or model codes
- All associated serial numbers.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MUE
- 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