Ingenuity Flex — Class II medical device recall Z-2113-2016
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2016-07-06. Supplier design change contributed to a thinner plastic which was used as part of the cover on the devices. Th
| Recall number | Z-2113-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Medical Systems (Cleveland) Inc, Cleveland, OH, United States |
| Recall initiated | 2016-06-21 |
| Classified | 2016-06-30 |
| Reported by FDA | 2016-07-06 |
| Terminated | 2018-07-02 |
| Countries outside the US | CH, CN, DE, DK, ES, GB, HU, IT, PH, SE, TH |
| Quantity | 10 units |
| Reason classes | packaging |
| Model numbers | 728317 |
Product
Ingenuity Flex, model # 728317; Intended to produce cross- sectional images of the body.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2113-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.