FDA Device recall Z-2382-2016
Brilliance iCT SP Model No. 728311
- FDA Device
- Class II
- terminated
- Published 2016-08-17
On 2016-08-17 the FDA classified a Class II recall of Brilliance iCT SP Model No. 728311 by Philips Medical Systems Cleveland, citing software issues found in v4.1 .3/4.1.5 in the Philips Brilliance iCT/ iCT SP products that could affect the performance of the equipment.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2382-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-04-29 |
| Published | 2016-08-17 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WV, WY |
Product
Brilliance iCT SP Model No. 728311; To produce cross-sectional images of the body.
Reason
Software issues found in v4.1 .3/4.1.5 in the Philips Brilliance iCT/ iCT SP products that could affect the performance of the equipment.
Identifiers
| code_info | Brilliance iCT SP Model No. 728311 S/N:200107,200003,200011,200009,200017,200074,200022,200013,200027,200049,200032,…Brilliance iCT SP Model No. 728311 S/N:200107,200003,200011,200009,200017,200074,200022,200013,200027,200049,200032, 200030,200043,200040,200038,200047,200051,200044,200063,200061,200068,200067, 200089,200088,200092,200093,200101,200097,200100,200105,200109,200121,200204, 200111,200117,200127,200131,200200,200205,200138,200202,200201,200203,200209, 200210,200206,200208,200207,200211,200019,200015,200029,200024,200023,200025, 200026,200041,200086,200102,200213 |
|---|
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-2382-2016%22
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