GE Healthcare Coils FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

  • Latest inspection NAI · Apr 20, 2012
  • No warning letters matched by name
Inspections 1 0 OAI
Recalls 0 0 Class I
Warning letters 0 None on file
510(k) clearances 0 None on file

GE Healthcare Coils has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "GE Healthcare Coils" is on file.

What these totals cover: FDA records filed under the name "GE Healthcare Coils". Records filed under related names are not included; see Related names.

Latest recall
Z-3171-2026 · Jul 31, 2026 · filed under Ge Healthcare
Latest inspection
Apr 20, 2012 · NAI

Newer recall under related name Ge Healthcare: Jul 31, 2026, Z-3171-2026.

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections1Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

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Recent FDA inspections

1 inspection on Apr 20, 2012.

DateSiteProductClassificationFEI
Apr 20, 2012Aurora, OHDevicesNo Action Indicated (NAI)3005214683
NAI
No objectionable conditions or practices were found during the inspection.
VAI
Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI
Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

1 inspected site, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3005214683Aurora, OH1Apr 20, 2012

GE Healthcare Coils and the FDA: common questions

Has GE Healthcare Coils received an FDA warning letter?

No FDA warning letter addressed to the name "GE Healthcare Coils" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has GE Healthcare Coils received an FDA Form 483?

FDA has not published a Form 483 for "GE Healthcare Coils" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect GE Healthcare Coils?

The most recent FDA inspection on file ended Apr 20, 2012 at Aurora, OH and was classified NAI. FDA has 1 inspection of GE Healthcare Coils on file.

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Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.