FDA Device recall Z-2115-2016
Ingenuity Core, model # 728326
- FDA Device
- Class II
- terminated
- Published 2016-07-06
On 2016-07-06 the FDA classified a Class II recall of Ingenuity Core, model # 728326 by Philips Medical Systems Cleveland, citing supplier design change contributed to a thinner plastic which was used as part of the cover on the devices. The thinner plastic cover may crack causing injury to patients, operato….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2115-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-06-21 |
| Published | 2016-07-06 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | n/a |
Product
Ingenuity Core, model # 728326; Intended to produce cross- sectional images of the body.
Reason
Supplier design change contributed to a thinner plastic which was used as part of the cover on the devices. The thinner plastic cover may crack causing injury to patients, operators, by-standers and service personnel.
Identifiers
| code_info | 901510 |
|---|
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-2115-2016%22
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