Known Identifiers & Locations
FEI Numbers
2126677
Owner Operator Numbers
N/A
Locations Covered
N/A
Registered Establishments (0)
No device registration and listing records found for this entity.
510(k) Premarket Notifications (0)
No 510(k) notifications found for this entity.
FDA Recall History (3)
| Recall # |
Product Description |
Initiation Date |
Status |
Action |
| Z-0002-2009 |
Revolution XR/d system control room PC model 5117866-2 with Software collector 5115434
Reason: GE Healthcare has recently become aware of a potential risk of observing a blank image after exposure on
Revolution XR/d systems equipped with HP 8200 PC user consoles that may impact patient safety.
It was reported that images acquired with off-center collimation for extremities with the
position selected as Digits to front or Digits to back are displayed as blank. Investigation into
th
|
2008-02-14 |
Terminated
|
View Details
|
| Z-0003-2009 |
Revolution XR/d systems with control room PC model 5117866-2 with Software collector 5194381. GE Healthcare, 3000 North Grandview, Waukesha, WI 53188.
Intended for use in generating Tomographic images of human anatomy.
Reason: GE Healthcare has recently become aware of an error in the generator software on the Revolution XR/d
configured with HP 8200 PC consoles that reports a mAs reading that is higher than is actually exposed to patients.
|
2008-02-14 |
Terminated
|
View Details
|
| Z-0007-2011 |
HiSpeed X/i Computed Tomography operator consoles with the Model Number 2153675 and 2247802.
The expected usage of this product is to generate head and whole body CT images of human subjects.
Reason: It was discovered that the operator console did not have a label affixed in accordance with 21CFR 1010.2 indicating certification to applicable performance standards.
|
2009-05-01 |
Terminated
|
View Details
|
Profile Disclaimer
AvaSpecs compiles public data records from the FDA database. This compiled profile does not indicate endorsement, safety, clearance, approval, or compliance status. AvaSpecs is a private search index and is not affiliated with the FDA or any government agency.