The Recall Desk
HighFDA (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.

What this means for you

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
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:

Related recalls

Same manufacturer · GE Healthcare, LLC

See all →

Same hazard · falling object

See all →