FDA Device recall Z-1101-2021
GE Healthcare Precision 600FP, Classical R&F (radiographic and fluoroscopic) System - Product Usage: Intended for use by a qualified/traine…
- FDA Device
- Class II
- terminated
- Published 2021-02-17
On 2021-02-17 the FDA classified a Class II recall of GE Healthcare Precision 600FP, Classical R&F (radiographic and fluoroscopic) System - Product Usage: Intended for use by a qualified/traine… by Ge Healthcare, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1101-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-12-10 |
| Published | 2021-02-17 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ge Healthcare |
| Distribution | US |
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
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.
Identifiers
| code_info | Serial Numbers: G1D1842032, G1D1842035, G1C17X2022, G1D1852039, Not Available*, G1D1922084, G1B16X2002, G1D1972106, G1…Serial Numbers: G1D1842032, G1D1842035, G1C17X2022, G1D1852039, Not Available*, G1D1922084, G1B16X2002, G1D1972106, G1D18X2058, G1D18Y2066, G1B1912074, G1B1772014, G1C1782016, G1D1842033, G1D18Z2071, G1D1962102, G1D1962104, G1D1862041, G1D18Y2068, G1D1972107, G1D18Z2069, Not Available*, G1D19X2118, G1D1982112, Not Available*, G1D1862043, G1D18Y2065, Not Available*, G1D1962101, G1C17X2026, G1D1832029, G1D1962105, G1B1772012, G1D1832030, G1B1772012, G1D1852038, Not Available, G1D1842031, G1C17X2023, G1C1782017, G1D1892054, G1D1932088, G1C17X2024, G1D1882049, G1D1882048, G1D1912077, G1D1932089, GID194092, G1923001923, G1793810017, G1D1882052, G1D1922080, G1D1862045, G1D1882051, G1C1792020, G1D1892055, G1D1932090, G1B1742006, G1D18Z2070, G1D1862042, G1D18X2062, G1D18X2061, G1B1762011, G1B1762010, G1D1942093, G1D1862044, G1D1882050, G1B1912079, G1D1992113, G1B1762009, G1D1852036, G1D1992117, G1D1842034, G1D1922083, G1D1952097, G1D18Z2073, G1D18X2060, G1D1912078, G1D1922085, G1D1892057, Not |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1101-2021%22
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