FDA Device recall Z-1747-2019
Optima PET/CT 560, 560FX Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography…
- FDA Device
- Class II
- ongoing
- Published 2019-06-26
On 2019-06-26 the FDA classified a Class II recall of Optima PET/CT 560, 560FX Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography… by Ge Healthcare, citing GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1747-2019 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-02-12 |
| Published | 2019-06-26 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
Optima PET/CT 560, 560FX 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.
Reason
GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure
Identifiers
| code_info | CT 560, 560FX |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1747-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.