GE Healthcare Precision 600FP — Class II medical device recall Z-1101-2021
Terminated recall by GE Healthcare, LLC, reported 2021-02-17, distributed nationwide. GE Healthcare has become aware of a potential safety issue associated with the improper installation of the Pr
| Recall number | Z-1101-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2020-12-10 |
| Classified | 2021-02-09 |
| Reported by FDA | 2021-02-17 |
| Terminated | 2022-11-18 |
| Distributed | Nationwide (US) |
| Quantity | 113 units |
| Reason classes | device malfunction |
| Serial numbers | G1B16X2002, G1B1772012, G1B1772014, G1B1912074, G1C1782016, G1C17X2022, G1C17X2026, G1D1832029, G1D1832030, G1D1842032, G1D1842033, G1D1842035, G1D1852038, G1D1852039, G1D1862041, G1D1862043, G1D18X2058, G1D18Y2065, G1D18Y2066, G1D18Y2068, G1D18Z2069, G1D18Z2071, G1D1922084, G1D1962101, G1D1962102 and 6 more |
Product
GE Healthcare Precision 600FP, Classical R&F (radiographic and fluoroscopic) System - Product Usage: Intended for use by a qualified/trained doctor or technologist on both adult and pediatric subjects taking diagnostic radiographic and fluoroscopic exposures of the whole body, skull, spinal column, chest, abdomen, extremities and other body parts.
Reason for recall
GE Healthcare has become aware of a potential safety issue associated with the improper installation of the Precision 600FP monitor suspension. A partial detachment of the monitor suspension could result in potential injury to a patient or operator.
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-1101-2021. 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.