GE Inspection Technologies — Class II medical device recall Z-2236-2016
Terminated recall by GE Inspection Technologies, LP, reported 2016-08-03, distributed in FL, TN, TX. Radiation emissions which exceeded the limit in the performance standard were detected during maintenance of o
| Recall number | Z-2236-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | FDA mandated |
| Recalling firm | GE Inspection Technologies, LP, Lewistown, PA, United States |
| Recall initiated | 2016-03-02 |
| Classified | 2016-07-22 |
| Reported by FDA | 2016-08-03 |
| Terminated | 2017-08-07 |
| Distributed | FL, TN, TX |
| Quantity | 4 |
Product
GE Inspection Technologies, LP - Phoenix v|tome|x m240 cabinet x-ray systems. A microfocus CT system used primarily for 3D metrology and analysis.
Reason for recall
Radiation emissions which exceeded the limit in the performance standard were detected during maintenance of one system. The identified cause was insufficient attachment of shielding in the door. Jostling during delivery was identified as the probable cause of this failure to comply with the performance standard.
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-2236-2016. 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.