CombiDiagnost R90 Image-Intensified fluoroscopic x-ray system… — Class II medical device recall Z-0330-2018
Terminated recall by Philips Electronics North America Corporation, reported 2018-01-17. The tube adapter-plate green/yellow protective earthing (PE) wire was removed. and spacers with different thic
| Recall number | Z-0330-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Electronics North America Corporation, Andover, MA, United States |
| Recall initiated | 2017-10-19 |
| Classified | 2018-01-10 |
| Reported by FDA | 2018-01-17 |
| Terminated | 2018-09-20 |
| Countries outside the US | DE, FR, LU, NZ |
| Quantity | 10 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0330-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.