FDA Device recall Z-2370-2016
Brilliance CT 16 Power Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstructi…
- FDA Device
- Class II
- terminated
- Published 2016-08-17
On 2016-08-17 the FDA classified a Class II recall of Brilliance CT 16 Power Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstructi… by Philips Medical Systems Cleveland, citing software defect causing intermittently slow response of Host.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2370-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-03-24 |
| 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, DC, 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 CT 16 Power Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Reason
Software defect causing intermittently slow response of Host.
Identifiers
| code_info | Model #: 728240; Serial #s: 3100, 3236, 5043, 5047, 5280, 5345, 5390, 5395, 5413, 5430, 5476, 5495, 5499, 5500, 5512, 6…Model #: 728240; Serial #s: 3100, 3236, 5043, 5047, 5280, 5345, 5390, 5395, 5413, 5430, 5476, 5495, 5499, 5500, 5512, 6007, 6009, 6013, 6032, 6041, 6045, 6049, 6051, 6058, 6062, 6064, 6066, 6067, 6070, 6071, 6077, 6080, 6081, 6084, 6089, 6095, 6098, 6100, 6106, 6109, 6113, 6115, 6116, 6119, 6120, 6123, 6124, 6131, 6132, 6134, 6141, 6144, 6155, 6161, 6162. |
|---|
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-2370-2016%22
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