Facility

Given Imaging Vietnam Co., Ltd.

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

Key facts

2recalls · worst Class I

1inspections · worst NAI

—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)	3007662958
Establishment type	Manufacture Medical Device
Location	Suite 6A, 6 floor, Standard Factory Bldg., 14th Street Ho Chi Minh City, VN District 7
Registration status	Active · expires 2026
Parent company	GIVEN IMAGING INC. (owner-operator 10091555)
Brand names	Reflux software; Versaflex pH Z catheters; Versaflex pH catheters; pHersaflex pH catheters; AccuView pH & pH-Z software; Digitrapper pH Z

Activity by year

Recalls (2)
Inspections (1)

Devices registered here (1)

Electrode, Ph, Stomach
Product code FFT (opens in a new tab) · Class I · Gastroenterology, Urology · 21 CFR 876.1400

Recalls & enforcement

Class IOngoing2026-08-06
Capsule may fail to attach to the esophagus or detach from the delivery device. Risks include patient aspiration/inhalation, perforation of esophagus, obstruction of the airway, hemorrhage/blood loss/bleeding, laceration of the esophagus, a delay in diagnosis, and foreign bodies …
Class IOngoing2025-06-03
It has been determined that misapplied adhesive on the Bravo CF capsule delivery device may lead to its malfunction. Specifically, the misapplied adhesive may prevent the capsule from attaching to the patient's esophagus or detaching from the delivery device.

FDA inspections (1)

NAI2024-07-19
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.

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. “Given Imaging Vietnam Co., Ltd. (FEI 3007662958) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3007662958-given-imaging-vietnam-co-ltd/

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