GE Precision MPi is an all-digital multipurpose tilt-C x-ray system — Class II medical device recall Z-0753-2016
Terminated recall by Regulatory Insight, Inc, reported 2016-03-02, distributed in CA, CO, FL, IN, MA, MI, MN, MS…. It was discovered that the Remote Touch Panel (RTP) of the GE Precision MPi X-ray system may not always boot u
| Recall number | Z-0753-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Regulatory Insight, Inc, Littleton, CO, United States |
| Recall initiated | 2008-07-01 |
| Classified | 2016-02-24 |
| Reported by FDA | 2016-03-02 |
| Terminated | 2017-07-11 |
| Distributed | CA, CO, FL, IN, MA, MI, MN, MS, NV, NY, OH, OR, PA, TN, VT, WA, WI |
| Quantity | 43 |
Product
GE Precision MPi is an all-digital multipurpose tilt-C x-ray system, intended for a multitude of diagnostic procedures, including radiology, fluoroscopy, interventional procedures, vascular and non-vascular procedures, and specialized applications including angiographic studies.
Reason for recall
It was discovered that the Remote Touch Panel (RTP) of the GE Precision MPi X-ray system may not always boot up as intended and needs to be updated to properly accomplish its intended purpose.
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-0753-2016. 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.