Philips Brilliance iCT SP Computed Tomography X-Ray System — Class II medical device recall Z-1922-2020
Terminated recall by Philips North America, LLC, reported 2020-05-13, distributed in IA. The bolt affixing the cooling unit to the rotor was not tightened to specification on the Philips Brilliance i
| Recall number | Z-1922-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America, LLC, Andover, MA, United States |
| Recall initiated | 2020-04-06 |
| Classified | 2020-05-06 |
| Reported by FDA | 2020-05-13 |
| Terminated | 2022-09-16 |
| Distributed | IA |
| Quantity | 2 |
| Serial numbers | 200044 |
| Model numbers | 728311 |
Product
Philips Brilliance iCT SP Computed Tomography X-Ray System; Model # 728311
Reason for recall
The bolt affixing the cooling unit to the rotor was not tightened to specification on the Philips Brilliance iCT systems.
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-1922-2020. 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.