FDA Device recall Z-1356-2016
Ingenuity CT Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X-ray…
- FDA Device
- Class II
- terminated
- Published 2016-04-20
On 2016-04-20 the FDA classified a Class II recall of Ingenuity CT Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X-ray… 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-1356-2016 |
| 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
Ingenuity CT 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. 728326; S/N: 30003, 30005, 30006, 30007, 30008, 30009, 30010, 30011, 30012, 30013, 30014, 30015, 30017, 30018…Model No. 728326; S/N: 30003, 30005, 30006, 30007, 30008, 30009, 30010, 30011, 30012, 30013, 30014, 30015, 30017, 30018, 30019, 30020, 30021, 30022, 30025, 30026, 30027, 30028, 30029, 30030, 30031, 30032, 30033, 30034, 30036, 30037, 30038, 30039, 30040, 30041, 30042, 30043, 30044, 30045, 30046, 32083, 52051, 300004, 300015, 300033, 300037, 300038, 300045, 300054, 300057, 300066, 300068, 300072, 300081, 300082, 300084, 30008, 300091, 300107, 300109, 300120, 300122, 300141, 300142, 300149, 300150, 300156, 300157, 300207, 300208, 300209, 300210, 300211, 30004-1, 1, 3, 941055, 30047, 30049, 300146, 300212, 95742 & 941091. |
|---|
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-1356-2016%22
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