FDA Device recall Z-1353-2016
Brilliance iCT SP Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X…
- FDA Device
- Class II
- terminated
- Published 2016-04-20
On 2016-04-20 the FDA classified a Class II recall of Brilliance iCT SP Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X… by Philips Medical Systems Cleveland, citing the firm was notified of a software error in which the system may not automatically send all image/data series to remote devices.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1353-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-02-05 |
| Published | 2016-04-20 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WV |
Product
Brilliance iCT SP Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes
Reason
The firm was notified of a software error in which the system may not automatically send all image/data series to remote devices.
Identifiers
| code_info | Model No. 728311; S/N: 200011, 200013, 200017, 200022, 200027, 200030, 200032, 200038, 200040, 200047, 200049, 200051,…Model No. 728311; S/N: 200011, 200013, 200017, 200022, 200027, 200030, 200032, 200038, 200040, 200047, 200049, 200051, 200061, 200063, 200067, 200068, 200074, 200088, 200093, 200097, 200100, 200101, 200105, 200107, 200109, 200111, 200117, 200121, 200127, 200131, 200138, 200200, 200201, 200202, 200203, 200204, 200205, 200206, 200207, 200208, 200209, 200210 & 200211. |
|---|
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-1353-2016%22
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