Brilliance iCT Computed Tomography X-ray system — Class II medical device recall Z-1695-2015
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2015-06-10. A calibrated torque wrench malfunctioned at the supplier leading to possible incorrect torque of x-ray tube mo
| Recall number | Z-1695-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Medical Systems (Cleveland) Inc, Cleveland, OH, United States |
| Recall initiated | 2015-04-13 |
| Classified | 2015-05-29 |
| Reported by FDA | 2015-06-10 |
| Terminated | 2015-10-01 |
| Countries outside the US | CN, NO |
| Quantity | 2 |
| Reason classes | device malfunction |
| Serial numbers | 85019, 85023 |
| Model numbers | 728306 |
Product
Brilliance iCT Computed Tomography X-ray system
Reason for recall
A calibrated torque wrench malfunctioned at the supplier leading to possible incorrect torque of x-ray tube mounting fasteners.
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-1695-2015. 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.