GE — Class II medical device recall Z-1589-2016
Terminated recall by GE Medical Systems, LLC, reported 2016-05-11, distributed in FL, GA, NC, TX. An out of tolerance torque tool was used on three joints during the manufacturing process. If the X-ray Tube b
| Recall number | Z-1589-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Medical Systems, LLC, Waukesha, WI, United States |
| Recall initiated | 2016-04-20 |
| Classified | 2016-04-29 |
| Reported by FDA | 2016-05-11 |
| Terminated | 2016-09-21 |
| Distributed | FL, GA, NC, TX |
| Countries outside the US | AE, AU, CA, CN, DE, FR, GB, IT, JP, KR, NO, PE, SE |
Product
GE, Revolution CT. The system is intended for head, whole body, cardiac, and vascular X-ray Computed Tomography applications
Reason for recall
An out of tolerance torque tool was used on three joints during the manufacturing process. If the X-ray Tube becomes loose on the CT gantry during operation, this could result in beam tracking errors, potential scan aborts and/or a possible image artifact. There is a secondary safety mechanism to prevent components from being expelled from the gantry if the bolts fail.
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-1589-2016. 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.