Computed Tomography X-Ray System — Class II medical device recall Z-0801-2014
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2014-01-29, distributed nationwide. Machine Name in TumorLOC Basic Mode is obscured. When TumorLOC is in Basic Mode and Set Vertical Laser equals
| Recall number | Z-0801-2014 |
|---|---|
| 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 | 2013-12-04 |
| Classified | 2014-01-21 |
| Reported by FDA | 2014-01-29 |
| Terminated | 2015-07-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, CH, CN, ES, FR, ID, IN, IT, KR, MX, PL, RO, RU, TH, TW |
| Quantity | 32 units |
| Reason classes | labeling |
| Model numbers | 728243, 728244 |
Product
Computed Tomography X-Ray System (Brilliance CT Big Bore Oncology & Brilliance CT Big Bore Radiology) Distributed by Philips Healthcare System, Cleveland, OH. Produces cross-sectional body images by computer reconstruction of x-ray transmission data taken at different angles and planes.
Reason for recall
Machine Name in TumorLOC Basic Mode is obscured. When TumorLOC is in Basic Mode and Set Vertical Laser equals Yes, the Machine Name label and field are covered by the controls above it. The Machine Name cannot be viewed or changed.
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-0801-2014. 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.