FDAClass IIFebruary 17, 2021

GE Healthcare Precision 600FP recall

GE Healthcare Precision 600FP, Classical R&F (radiographic and fluoroscopic) System - Product Usage: Intended for use by a qualified/trained doctor or…

Why was GE Healthcare Precision 600FP recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
GE Healthcare Precision 600FP, Classical R&F (radiographic and fluoroscopic) System - Product Usage: Intended for use by a qualified/trained doctor or…
Recalling firm
GE Healthcare, LLC
Quantity
113 units
Distribution
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
Recall date
February 17, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls