Class 2 Device Recall KALARE (Precision 600FP)

• Date Initiated by Firm: December 10, 2020
• Create Date: February 09, 2021
• Recall Status: Terminated on November 18, 2022
• Recall Number: Z-1101-2021
• Recall Event ID: 87061
• 510(K)Number: K133553
• Product Classification: System, x-ray, fluoroscopic, image-intensified - Product Code JAA
• 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.
• 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
• Recalling Firm/ Manufacturer: GE Healthcare, LLC; 3000 N Grandview Blvd; Waukesha WI 53188-1615
• For Additional Information Contact: GE Healthcare Service; 800-437-1171
• Manufacturer 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.
• FDA Determined Cause: Other
• Action: The firm issued an urgent medical device correction notice by letter on 12/10/2020. The letter states: "You can continue to use your Precision 600 FP monitor suspension under the following condition. If you observe any abnormal movement or misalignment of the monitor suspension in day to day performance controls, discontinue use and contact your GE Healthcare Service Representative immediately." Customers with questions or concerns may contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
• Quantity in Commerce: 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = JAA