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Recall Observatory FDA recall evidence

Device 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.

Z-1101-2021

December 10, 2020

Class II

Product summary

Firm
GE Healthcare, LLC
Event
Event 87061
Status
Terminated
Classification
Class II
Quantity
113 units
Official record key
device-enforcement:Z-1101-2021

Official wording

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.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.