# FDA recall Z-1101-2021

> **GE Healthcare, LLC** · Class II · device recall initiated 2020-12-10.

## 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.

## 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.

## 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

## Key facts

- **Recall number:** Z-1101-2021
- **Recalling firm:** GE Healthcare, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-12-10
- **Report date:** 2021-02-17
- **Termination date:** 2022-11-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Waukesha, WI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1101-2021

## Citation

> AI Analytics. FDA recall Z-1101-2021. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/Z-1101-2021. Source: US FDA. Licensed CC0.

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