ModerateClass IITerminated

FDA Devices recall · Reported February 17, 2021

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.

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on February 17, 2021. Severity: Moderate. Recall number: Z-1101-2021.

Q: Where was the recalled product distributed?

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.

Q: Should I stop using a recalled medication or medical device?

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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…

Recall #: Z-1101-2021
Affected scope: 113 units
Initiated: December 10, 2020

Compiled from official public sources by the publisher. · Updated September 2026

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Ge Healthcare, LLC recalled GE Healthcare Precision 600FP, Classical R&F (radiographic and fluoroscopic) System - Pr… - a moderate-severity action.

GE Healthcare Precision 600FP, Classical R&F (radiographic and fluoroscopic) System - Pr… was recalled by Ge Healthcare, LLC in February 17, 2021. Reason: GE Healthcare has become aware of a potential safety issue associated with the improper installation of the P…. Check the official notice for the remedy. Verify recall #Z-1101-2021 with the FDA Devices before acting.

The recall

Ge Healthcare, LLC issued this moderate-severity FDA Devices recall-GE Healthcare has become aware of a potential safety issue associated with the improper installation of the P….

Moderate
severity level: 113 units
affected scope: Class II
classification: February 17, 2021
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-1101-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

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.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	Z-1101-2021
Date reported	February 17, 2021
Date initiated	December 10, 2020
Recalling firm	Ge Healthcare, LLC
Firm location	Waukesha, WI
Affected scope	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

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

113 units units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-1101-2021) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on February 17, 2021. Severity: Moderate. Recall number: Z-1101-2021.

Where was the recalled product distributed? ▼

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.

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

Same archive severity grade (Moderate), closest by report date among other firms and states.

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Same product category, closest by report date among other firms and states (deduped against the severity set).

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This recall: FDA Devices, reported February 17, 2021. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026