No packaging — Class II medical device recall Z-2678-2014
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2014-10-01, distributed in AR, CA, FL, KY, LA, MA, MD, MI…. When the Extended Display Firled ov View reconstruction is used, the CT numbers and anatomy in teh extended re
| Recall number | Z-2678-2014 |
|---|---|
| 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 | 2007-01-09 |
| Classified | 2014-09-22 |
| Reported by FDA | 2014-10-01 |
| Terminated | 2015-11-06 |
| Distributed | AR, CA, FL, KY, LA, MA, MD, MI, MN, MO, NJ, NY, OH, PA, RI, SC, TX, VA, VT |
| Countries outside the US | AT, AU, BE, CA, DK, FI, FR, GB, MY, NL, NO, NZ |
| Quantity | 61 |
| Model numbers | 728243 |
Product
No packaging. The device is a computed tomography scanner. Intended to provide corss sectional images of the human body and visualization of the internal organs of the body.
Reason for recall
When the Extended Display Firled ov View reconstruction is used, the CT numbers and anatomy in teh extended region are not accurate.
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-2678-2014. 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.