Brilliance CT System 6/10/16/16P/40 configuration — Class II medical device recall Z-2709-2014
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2014-10-01, distributed in AZ, CO, GA, IA, IL, IN, KS, KY…. The system has a gap that can appear between the upper and lower tilt stand covers. The fingers may be squeeze
| Recall number | Z-2709-2014 |
|---|---|
| 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 | 2005-12-27 |
| Classified | 2014-09-25 |
| Reported by FDA | 2014-10-01 |
| Terminated | 2015-11-06 |
| Distributed | AZ, CO, GA, IA, IL, IN, KS, KY, MD, MI, MN, MS, NC, NY, OH, OK, TX, VT, WI |
| Countries outside the US | AT, AU, BE, BR, CH, CN, ES, FR, GB, IL, IN, IT, JP, KR, NL, NZ, SG, TR, TW, ZA |
| Quantity | 364 |
Product
Brilliance CT System 6/10/16/16P/40 configuration. No packaging, sold as single unit. Computed tomography scanner intended to provide cross sectional images of the human body and visualization of the internal organs.
Reason for recall
The system has a gap that can appear between the upper and lower tilt stand covers. The fingers may be squeezed if a person was to place them in this region while the gantry was tilting from an angle to zero tilt angle.
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-2709-2014. 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.