FDA Device recall Z-0593-2017
Brilliance iCT Computed Tomography X-ray system, Model 728306
- FDA Device
- Class III
- terminated
- Published 2016-11-23
On 2016-11-23 the FDA classified a Class III recall of Brilliance iCT Computed Tomography X-ray system, Model 728306 by Philips Medical Systems Cleveland, citing the product label does not include the correct current rating.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0593-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-10-13 |
| Published | 2016-11-23 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | AL, AZ, CO, GA, IN, KY, LA, MA, MN, NY, OH, OR, PA, SC, TN, TX, UT, VA |
Product
Brilliance iCT Computed Tomography X-ray system, Model 728306
Reason
The product label does not include the correct current rating.
Identifiers
| code_info | 85003, 85004, 85010, 85033, 85035, 85038, 85043, 85054, 85060, 100054, 100064, 100093, 100113, 100119, 100134, 100180,…85003, 85004, 85010, 85033, 85035, 85038, 85043, 85054, 85060, 100054, 100064, 100093, 100113, 100119, 100134, 100180, 100181, 100185, 100280, 100304, 100318, 100328, 100356, 100368, 100466, 100600, 100606, 100611, 100629, 100630, 100631, 100632, 100633, 100634, 100635, 100638, 100643, 100645, 100648, 100649, 100652, 100653, 100654, 100655, 100658, 100663, 100665, 100673, 100674, 100680, 100684, 100685, 100688, 100690, 100693, 100695, 100698, 100699, 100700, 100701, 100702, 100703, 100704, 100708, 100720, 100743, 200005 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0593-2017%22
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