GE Healthcare, LLC: Medical Device Recall in 2021 - (Recall #: Z-1101-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: December 10, 2020

Date Posted: February 17, 2021

Recall Number: Z-1101-2021

Event ID: 87061

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.

Status: Terminated

Product Quantity: 113 units

Code Information:

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 Available*, G1D1932091, G1D1922081, Not Available*, G1D1912075, G1D18Z2072, G1D1852040, G1D1892056, G1C1792021, G1D1982111, G1D1952100, G1B16X2005, G1D1952096, G1D1962103, G1D1922082, G1D1972108, Not Available*, G1D1932086, G1B16X2004, G1D1852037, G1D18X2059, G1D18Y2064, G1D18Y2063, G1B1942095, G1D1932087, G1D1913076, G1D18Y2067, G1D1872046, G1D1832028, G1D1992114, G1C1792018, G1C17X2025, G1B16X2003 not available* - to be supplied

Distribution Pattern:

US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NJ, NM, NV, NY, OH, PA, SC, TN, TX, UT, VA, WA, WI, WV

Voluntary or Mandated:

Voluntary: Firm initiated