Brilliance CT 64 — Class II medical device recall Z-1588-2013
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2013-07-03, distributed nationwide. If the operator selects a patient name from the worklist using the mouse and then selects a different patient
| Recall number | Z-1588-2013 |
|---|---|
| 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 | 2013-03-21 |
| Classified | 2013-06-25 |
| Reported by FDA | 2013-07-03 |
| Terminated | 2013-11-27 |
| Distributed | Nationwide (US) |
| Quantity | 50 units |
| Serial numbers | 300003, 300004, 300005, 300010, 300011, 300012, 300013, 300014, 300015, 300018, 300027, 300041, 300053, 300054, 300059, 300066, 300070, 300071, 300073, 300074, 300078, 300079, 300080, 300082, 300084 and 25 more |
Product
Brilliance CT 64, Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are whole body Computed Tomography X-ray systems. Produce cross-sectional images of the body by computer reconstruction of x-ray transmission.
Reason for recall
If the operator selects a patient name from the worklist using the mouse and then selects a different patient name using the keyboard (arrow keys then press enter) the patient name that populates the exam information page is the patient name selected with the mouse. Also, it is possible to begin a normal clinical scan while the anti-virus scan is running. However, if the user is running a bol
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-1588-2013. 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.