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.
FDA Recall Z-1101-2021 · Posted None
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Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeJAA
Date Initiated2020-12-10
Date Terminated2022-11-18
Product Quantity113 units
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.
Firm 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.
Root Cause
Other
Distribution Pattern
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
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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