FDA Device recall Z-0178-2016
Ingenuity Flex Computed Tomography X-ray systems
- FDA Device
- Class II
- terminated
- Published 2015-11-04
On 2015-11-04 the FDA classified a Class II recall of Ingenuity Flex Computed Tomography X-ray systems by Philips Medical Systems Cleveland, citing the firm discovered Ring/Dot artifact due to X-ray measurement error.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0178-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-09-14 |
| Published | 2015-11-04 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | US |
Product
Ingenuity Flex Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
Reason
The firm discovered Ring/Dot artifact due to X-ray measurement error.
Identifiers
| code_info | Model No. 728317; S/N: 1, 78807, 260002, 260003, 340002, 340003, 345001, 345002, 345003, 345004, 345005, 345006, 345007…Model No. 728317; S/N: 1, 78807, 260002, 260003, 340002, 340003, 345001, 345002, 345003, 345004, 345005, 345006, 345007, 345010, 345012, 345013, 345014, 345016, 345017, 345018, 345019, 345021, 345022, 345023, 345024, 345025, 345026, 345027, 345028, 345029, 345031, 345032, 345033, 345034, 345035, 345036, 345037, 345038, 345039, 345040, 345041, 345042, 345043, 345044, 345045, 345046, 345048, 345049, 345051, 345201, 345202, 345203, 345204, 345205, 345206, 345207, 345208, 345209, 345210, 345211, 345212, 345213, 345214, 345215, 345216, 345217, 345219, 345222, 345224 & 345228. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0178-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.