FDA Device recall Z-1647-2015
MX8000 Dualv
- FDA Device
- Class II
- terminated
- Published 2015-06-03
On 2015-06-03 the FDA classified a Class II recall of MX8000 Dualv by Philips Medical Systems Cleveland, citing the firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1647-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-03-16 |
| Published | 2015-06-03 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | n/a |
Product
MX8000 Dualv. EXP, 728130. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Reason
The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.
Identifiers
| code_info | MX8000 Dual v. EXP: System Code #, 728130, Serial #, 8107, 8128, 8152, 8157, 8171, 8212, 8236, 8245, 8263, 8320 & 8357. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1647-2015%22
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