Vital Signs Colorado Inc.: Vital Signs Anesthesia Circuits The Ventilator Circuit is intended for use as an interface between a ventilator dependent patient and a ventilator. The Anesthesia Circuit is intended to administer medical gases to a patient during anesthesia. The CPAP Circuit is intended to increase the airway pressure of a patient.

Recall number

Z-0812-2014

Recalling firm

Vital Signs Colorado Inc.

Product

Vital Signs Anesthesia Circuits The Ventilator Circuit is intended for use as an interface between a ventilator dependent patient and a ventilator. The Anesthesia Circuit is intended to administer medical gases to a patient during anesthesia. The CPAP Circuit is intended to increase the airway pressure of a patient.

Status

Terminated

Initiated

2013-12-26

Posted

2014-01-23

Terminated

2014-07-09

Reason

A circuit in use was occluded by a blue port cap that was inadvertently attached to the circuit as a result of an internal inspection error and will cause occlusion of gas flow.

Root cause

Process control

Action

GE Healthcare sent an Urgent Medical Device Correction letter on December 12, 2013 to all affected customers via certified letter to follow the safety instructions to: 1) Please follow all safety instructions in accordance with the instructions for use (IFU). 2) During installation, visually inspect the Vital Signs Breathing Circuits for any plugged ports. If 15mm or 22mm blue port caps are attached to any ports, please remove and discard. 3) Prior to use, the circuits should be pressure tested for leaks and flow tested for obstructions in accordance with the ventilator manufacturers specifications. The long-term solution is to update the instructions for the assembly operator and modify the circuit air test process by replacing the cap with a plug tethered to the workstation so the plug cannot be left on the circuit. If you have any questions or concerns regarding this notification, please contact GEMSIT Customer Service at +1-800-588-7044 (Domestic) or Vital Signs Customer Service at +1-800-932-0760 (International). Hours of Operation: 8:00 am EST to 6:00 pm EST. Please be assured that maintaining a high level of safety and quality is our highest priority. If you have any questions, please contact us immediately per the contact information above.

Quantity

1,827,920 units US , 504,760 units OUS

Distribution

Worldwide Distribution - USA (nationwide) including Puerto Rico; and Internationally to: Belgium, Canada, Chile, Mexico, Costa Rica, Kuwait, United Kingdom, Greece, Czech Republic, Latvia, Turkey, China, France, Italy, Brazil, Korea, Germany, Thailand, Egypt, Austria, Dominican Republic, India, Israel, Colombia, Japan, Netherlands, Venezula, Saudi Arabia, Argentina, Malaysia, Sweden, Lebanon, South Korea, Finland, United Arab Emirates, Taiwan, Panama, Uruguay, Singapore, Hong Kong, Ecuador, Peru, Oman, Spain, Lithuania, and South Africa.

Lot, serial or model codes

PartNumber : 4S78XX00,155512,155518,156505,156545,1576162,1576214,542011,542021,542031,1553196,1572347,1553402,156205,156310,1574701,1574710,1574711,1574712,1574723,1572414,A4JXXXXX,6463,C311123X,C6X1XX1X,207002,C316123X,1560023,201814,1730327,20CF800C,C116123X,1570103,20CT8050,1577112,1552016,A4JXOXXX,CXX61X2X,1552017,1552018,20CT8048,20CT8055,M1171508,M1181639,1552020,M1162025,155200EU,1552017CN,1574792,M1171508VS,M1181639VS,1552026,1552027,1552028,

510(k) numbers

["K831856"]

PMA numbers

not on file

Product code

CAH

Firm FEI

1718887

Firm city

Englewood

Firm state

CO

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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