Class II — GE Healthcare, LLC
| Recalling firm | GE HealthCare Technologies Inc. |
|---|---|
| Registered facility | View this company's 50 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| 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. |
| Quantity | 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 |
| Initiated | 2020-12-10 |
| Classified | 2021-02-09 |
| Terminated | 2022-11-18 |
| Recall number | Z-1101-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — GE Healthcare, LLC (Z-1101-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87061/
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