FDA Device recall Z-2678-2014
No packaging
- FDA Device
- Class II
- terminated
- Published 2014-10-01
On 2014-10-01 the FDA classified a Class II recall of No packaging by Philips Medical Systems Cleveland, citing when the Extended Display Firled ov View reconstruction is used, the CT numbers and anatomy in teh extended region are not accurate.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2678-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2007-01-09 |
| Published | 2014-10-01 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | AR, CA, FL, KY, LA, MA, MD, MI, MN, MO, NJ, NY, OH, PA, RI, SC, TX, VA, VT |
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
When the Extended Display Firled ov View reconstruction is used, the CT numbers and anatomy in teh extended region are not accurate.
Identifiers
| code_info | Model 728243 Software version 2.2.1 and 2.2.2 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2678-2014%22
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