Vital Signs- A GE Healthcare Company - Hygroscopic Condenser Humidifier (HCH)/Anesthesia Breathing Circuit; GE Medical S

FDA device recall Z-2848-2011 · posted 2011-07-30 · Terminated

Recall details

Recalling firm

Vital Signs Devices, a GE Healthcare Company

Reason for recall

The Hygroscopic Condenser Humidifier (HCH) device may have an occlusion that can prevent proper flow of the medical gases or oxygen, possibly resulting in insufficient oxygen delivered to the patient.

Action taken

An "Urgent Medical Device Correction" letter with the return confirmation form was sent to affected customers. Phone calls were also placed to customers. Consignees were informed of the affected device, issue, and actions to take. Customers were instructed to isolate all affected product, arrange return by contacting Customer Service at 1-800-932-0760, and return only unused product. Customers were asked to complete the attached confirmation form and fax back as per the instructions. For questions, contact your local Vital Signs Account Manager or call Customer service at 1-800-932-0760.

Root cause

Device Design

Status

Terminated

Product code

BYD

Quantity affected

222,009

Distribution

Worldwide Distribution including the United States.

Date initiated

2011-04-29

Date posted

2011-07-30

Date terminated

2014-08-06

Location

Totowa, NJ