FDA Medical Device Recalls (openFDA)
GE Healthcare, LLC: Discovery Ml Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images.
- Recall number
- Z-1749-2019
- Recalling firm
- GE Healthcare, LLC
- Product
- Discovery Ml Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images.
- Status
- Open, Classified
- Initiated
- 2019-02-12
- Posted
- 2019-06-19
- Terminated
- not on file
- Reason
- GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure
- Root cause
- Radiation Control for Health and Safety Act
- Action
- GE Healthcare sent a notification letter to affected customer (Hospital Administrators/Risk Managers. Managers of Radiology/Cardiology, Radiologist/Cardiologist). The letter identified the affected product, problem and actions to be taken. Customers were informed GE Healthcare will without charge, remedy the defect or bring the product into compliance. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
- Quantity
- 1113 in total
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Discovery Ml
- 510(k) numbers
- ["K161574"]
- PMA numbers
- not on file
- Product code
- KPS
- 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