Facility

IMACOR, Inc

2 recall(s) on record — most severe on record: Class II.

Key facts

2recalls · worst Class II

3inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3006382185
Establishment type	Develop Specifications But Do Not Manufacture At This Facility; Manufacture Medical Device
Location	50 Jericho Turnpike Jericho, NY, US 11753
Registration status	Active · expires 2026
Parent company	ImaCor Inc (owner-operator 10023490)
Brand names	Zura; ImaCor Zura TEE system; ImaCor Zura Inaging System

Activity by year

Recalls (2)
Inspections (3)

Devices registered here (3)

Transducer, Ultrasonic, Diagnostic
Product code ITX (opens in a new tab) · Class II · Radiology · 21 CFR 892.1570
Echocardiograph
Product code DXK (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.2330
System, Imaging, Pulsed Echo, Ultrasonic
Product code IYO (opens in a new tab) · Class II · Radiology · 21 CFR 892.1560

Recalls & enforcement

Class IIOngoing2025-08-29
Production assembly error resulting in the potential for reversed articulation, where moving the lever forward caused the probe tip to anteflex rather than retroflex, and vice versa.
Class IIOngoing2024-09-16
Epoxy used to seal the edge of the transducer into its paddle exceeded specification. This variability could attenuate the ultrasound signal with a potential impact on the quality of images obtained from the probes.

FDA inspections (3)

NAI2023-10-19
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
VAI2021-06-10
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2019-03-26
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by ImaCor Inc

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “IMACOR, Inc (FEI 3006382185) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3006382185-imacor-inc/

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