FDA Medical Device Recalls (openFDA)
GE Healthcare, LLC: HiSpeed FX/I (2200997-2 with Gantry mo. #2249696)
- Recall number
- Z-0781-2011
- Recalling firm
- GE Healthcare, LLC
- Product
- HiSpeed FX/I (2200997-2 with Gantry mo. #2249696)
- Status
- Terminated
- Initiated
- 2010-02-01
- Posted
- 2011-01-04
- Terminated
- 2014-05-21
- Reason
- A defect with the hardware and software displaying the incorrect dose data.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- Important Electronic Product Radiation Warning letter was sent to customers identifying the affected product, explaining the defect and related hazards, giving instructions, and the product correction. Customers are to decrease the CTDI value by a factor of 30% when using 5, 7, 10 mm slice thickness, and by a factor of 20% when using 3 mm slice thickness for more accurate estimate of the CTDI. GE Healthcare will remedy the defect free of charge and provide an updated Operator Manual and configuration update to correct the CTDI display to all affected systems. Questions should be directed to the contact numbers provided in the letter.
- Quantity
- 102 total
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- With Gantry model numbers 2200997, 2200997-2, 2201000, 2201000-2, 2249696 and 2249696-2.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JAK
- 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