Z-1101-2021Class II

GE Healthcare Precision 600FP, Classical R&F (radiographic and fluoroscopic) System -

Name: Z-1101-2021 GE Healthcare Precision 600FP, Classical R&F (radiographic and fluoroscopic) System -
Creator: GE Healthcare, LLC
Published: 2020-12-10
License: https://open.fda.gov/license/

GE Healthcare / initiated 2020-12-10 / Terminated

FDA source

GE Healthcare, LLC began a recall of GE Healthcare Precision 600FP, Classical R&F (radiographic and fluoroscopic) System - Product Usage: Intended for use by a qualified/trained doctor or... on 2020-12-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1101-2021
Classification: Class II
Status: Terminated
Initiated: 2020-12-10
Posted: 2021-02-09
Terminated: 2022-11-18
Recalling firm: GE Healthcare
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.
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
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 root 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1101-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1101-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-17	2021-02-09

Product code JAA

K133553Class IIKalareToshiba America Medical Systems, In.C / cleared 2014-06-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)