Facility

EDAN Diagnostics, Inc.

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

Key facts

3recalls · worst Class II

—inspections in our data

—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)	3009499478
Establishment type	Manufacture Medical Device for Another Party (Contract Manufacturer)
Location	9918 Via Pasar San Diego, CA, US 92126
Registration status	Active · expires 2026
Parent company	EDAN Diagnostics, Inc. (owner-operator 10043671)
Brand names	PC ECG: SE-1515

Activity by year

Recalls (3)

Devices registered here (1)

Electrocardiograph
Product code DPS (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.2340

Recalls & enforcement

Class IIOngoing2025-10-24
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Class IITerminated2017-11-17
Firm became aware that it distributed 7 units in the U.S. that included a function that had not been cleared by U.S. FDA.
Class IITerminated2016-06-23
Incorrect CO2 readings with some patient monitors.

All facilities operated by EDAN Diagnostics, 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. “EDAN Diagnostics, Inc. (FEI 3009499478) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3009499478-edan-diagnostics-inc/

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