Agency classClass IIOur severity:High FDA (Devices)·Z-1101-2021·Announced 2021-02-17

GE Healthcare Precision 600FP Monitor Suspension Recall

GE Healthcare is recalling 113 Precision 600FP systems due to a potential monitor suspension defect that could cause injury.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

GE Healthcare, LLC is recalling 113 units of the Precision 600FP Classical R&F System. The recall is due to a potential safety issue involving the improper installation of the monitor suspension. A partial detachment of this component could result in potential injury to a patient or operator.

The affected systems were distributed nationwide in the United States, 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, and WV. The systems are intended for use by qualified doctors or technologists for diagnostic radiographic and fluoroscopic exposures.

Facilities should identify affected units by checking the serial numbers listed in the official recall notice. Users should contact GE Healthcare for instructions on how to address the installation issue.

The recalled product

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…
Manufacturer: GE Healthcare, LLC
Category: Medical Device — Radiology Equipment
Hazard: falling-object
physical-injury
Affected units: 113

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Serial Numbers: G1D1842032
G1D1842035
G1C17X2022
G1D1852039
Not Available*
G1D1922084
G1B16X2002
G1D1972106
G1D18X2058
G1D18Y2066
G1B1912074
G1B1772014
G1C1782016
G1D1842033
G1D18Z2071
G1D1962102
G1D1962104
G1D1862041
G1D18Y2068
G1D1972107

Distribution

Distributed nationwide across the United States.

The notice also names 34 states specifically:

Same manufacturer · GE Healthcare, LLC

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