GE Healthcare, LLC Recall 88150
Description: Revolution CT
GE Healthcare, LLC Recall 88150 Information
| Status | Ongoing |
| Mandated? | FDA Mandated |
| Recall Number | Z-2004-2021 |
| Event ID | 88150 |
| Event Description | Revolution CT |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide |
| Quantity | 197 (US = 40; OUS = 157) |
| Recall Reason | GE Healthcare has become aware of a potential issue on the Revolution CT system where a collimator blade does not find its appropriate home position. This issue could result in the delivered dose of x-ray radiation being either larger or smaller than its prescribed value. |
| Device Classification | 20210714 |
| Device Code Info | 5590000 5590000-6 5590000-2 |
| Center Classification Date | 20210708 |
| Recall Initiation Date | 20210319 |
| Recalling Firm | GE Healthcare, LLC |
| Initial Notification | Letter |
| Similar To |