FDA Device recall Z-0330-2018
CombiDiagnost R90 Image-Intensified fluoroscopic x-ray system CombiDiagnost R90 is a multi-functional general R/F system
- FDA Device
- Class II
- terminated
- Published 2018-01-17
On 2018-01-17 the FDA classified a Class II recall of CombiDiagnost R90 Image-Intensified fluoroscopic x-ray system CombiDiagnost R90 is a multi-functional general R/F system by Philips Electronics North America, citing the tube adapter-plate green/yellow protective earthing (PE) wire was removed. and spacers with different thickness were used to position pre-loc ring in respect to focal spot in….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0330-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-10-19 |
| Published | 2018-01-17 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Electronics North America |
| Distribution | n/a |
Product
CombiDiagnost R90 Image-Intensified fluoroscopic x-ray system CombiDiagnost R90 is a multi-functional general R/F system. It is suitable for all routine radiography and fluoroscopy exams, including specialist areas like angiography or pediatric work, excluding mammography
Reason
The tube adapter-plate green/yellow protective earthing (PE) wire was removed. and spacers with different thickness were used to position pre-loc ring in respect to focal spot in specified distance.
Identifiers
| code_info | All CombiDiagnost R90 UDI 709030 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0330-2018%22
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