[Recalled] Philips Healthcare Brilliance 64 Computed Tomography X-Ray System — Software Defects resulting in: (1) sagittal result shortened for axial scans | FDA 2015-09-06
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| Product | Philips Healthcare Brilliance 64 Computed Tomography X-Ray System |
|---|---|
| Brand / manufacturer | Philips Healthcare |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1713-2016 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 06 September 2015 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3) scan length changes with a change in field of view; (4) DoseRight algorithm miscalculations leading to incorrect CTDI values; (5) scan length changes during subsequent axial results, (6) surview scan lengths near 135mm or 184mm
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Philips Healthcare
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.