Facility

AS SOFTWARE, LLC

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

Key facts

1recalls · worst Class II

2inspections · 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)	3005207094
Establishment type	Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device
Location	560 Sylvan Ave Englewood Cliffs, NJ, US 07632
Registration status	Active · expires 2026
Parent company	AS SOFTWARE (owner-operator 9074082)
Brand names	AS Asera

Activity by year

Recalls (1)
Inspections (2)

Devices registered here (1)

System, Image Processing, Radiological
Product code LLZ (opens in a new tab) · Class II · Radiology · 21 CFR 892.2050

Recalls & enforcement

Class IITerminated2018-09-20
Any change made to current ultrasound machine software or hardware upgrades, adding or modifying custom fields, or adding a new Ultrasound Machine, must be tested prior to the use in production environment to ensure that ultrasound measurements are crossing over correctly to the …

FDA inspections (2)

NAI2024-04-29
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
NAI2018-08-16
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

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 AS SOFTWARE

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. “AS SOFTWARE, LLC (FEI 3005207094) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3005207094-as-software-llc/

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