GE HEALTHCARE CARESCAPE R860 Inspiratory Safety Guard, Part Numbers: a) 2066713-001 (single pack) b) 2083208-001 (box of

FDA device recall Z-0463-2019 · posted 2018-11-30 · Terminated

Recall details

Recalling firm

GE Healthcare, LLC

Reason for recall

The ventilator Inspiratory Safety Guard (ISG) may disconnect from the breathing circuit pathway. As a result, this could create a loss of ventilation which may lead to inadequate oxygenation for patients, increasing the possibility of hypoxia.

Action taken

The firm, GE Healthcare, initiated an "URGENT MEDICAL DEVICE CORRECTION" on 10/05/2018 by letter to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: Follow the safety instructions and If you have any incorrect ISGs, return to GE Healthcare or destroy on site, and complete and return the attached Customer Response form checking box #2 to indicate that you do have affected ISGs. E-mail the completed form to Recall34095.InspiratorySG@ge.com. Please ensure that all potential users in your facility are made aware of this safety notification and the recommended actions. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative. The firm initiated a new recall notice identifying a new issue on 02/01/2019

Root cause

Process control

Status

Terminated

Product code

CBK

Quantity affected

1140 units (307 units in US)

Distribution

Worldwide Distribution: US (Nationwide) including Puerto Rico, and to countries of: Albania, Argentina, Australia, Austria, Bangladesh, Bolivia, Bosnia and Herzegovina, Brazil, Cambodia, Canada, Chile

Date initiated

2018-10-05

Date posted

2018-11-30

Date terminated

2024-04-29

Location

Waukesha, WI

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