CLASS I Device recall · Reported 22 Jun 2016 · FDA Enforcement Report

TCA Board, 16542A A continuous ventilator intended to recalled

Carefusion 211 is recalling TCA Board, 16542A A continuous ventilator intended to mechanically control or assist, distributed nationwide in the US. The recall was initiated on 17 May 2016 and the FDA has classified it as Class I.

Recall details

Recall number: Z-1894-2016
FDA event ID: 74111
Recalling firm: Carefusion 211, Yorba Linda, CA
Classification: Class I
Status: Terminated
Recall initiated: 17 May 2016
FDA classified: 13 Jun 2016
Reported: 22 Jun 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: CPAP & Ventilators

Timeline

17 May 2016	Recall initiated by company
13 Jun 2016	Classified by FDA	+27 days
22 Jun 2016	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power to the User Interface Module (UIM).

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

TCA Board, 16542A A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.

Where it was distributed

Worldwide Distribution - US (Nationwide) and the countries of Australia, Hungary, Paraguay, Belgium, Indonesia, Philippines, Bolivia, Ireland, Poland, Bermuda, India, Saudi Arabia, Canada, Japan, Singapore, Chile, Jordon, South Africa, China, Kuwait, Taiwan, Ecuador, Malaysia, Thailand, Egypt, Mexico, Turkey, France, Netherlands, United Kingdom, Guatemala, and Nicaragua.

Nationwide

Questions about this recall

Is TCA Board, 16542A A continuous ventilator intended to mechanically control or assist recalled?

Yes. Carefusion 211 recalled TCA Board, 16542A A continuous ventilator intended to mechanically control or assist on 17 May 2016. The recall is Class I and its status is Terminated. Recall number Z-1894-2016.

Why was it recalled?

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Carefusion 211

All 12

Reported	Class	Recall	Company	Reason	Where
22 Jun 2016Device	CLASS I	AVEA Comprehensive ventilator-refurbished, R17310-xx recalled	Carefusion 211	Device Malfunction	Nationwide
22 Jun 2016Device	CLASS I	AVEA Comprehensive ventilator, 17310-xx (xx = recalled by Carefusion 211	Carefusion 211	Device Malfunction	Nationwide
22 Jun 2016Device	CLASS I	AVEA Standard ventilator-refurbished, R17311-xx recalled	Carefusion 211	Device Malfunction	Nationwide
22 Jun 2016Device	CLASS I	AVEA GDE upgrade kit, 12284-PMN A continuous ventilator recalled	Carefusion 211	Device Malfunction	Nationwide
22 Jun 2016Device	CLASS I	AVEA Standard with Compressor ventilator, 17312-xx (xx = recalled	Carefusion 211	Device Malfunction	Nationwide

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26 Aug 2026Device	CLASS II	Getinge Y Sensor Module, Servo-u, Servo-n recalled	Maquet Critical Care AB	Device Malfunction	Nationwide
19 Aug 2026Device	CLASS II	Biofire Respiratory Panel 1 (RP2.1) recalled by BioFire Diagnostics	BioFire Diagnostics	Other	Nationwide
5 Aug 2026Device	CLASS I	Astral 100/150 Resmed Astral 100/50 is a ventilator system recalled	ResMed	Packaging Defects	Nationwide
8 Jul 2026Device	CLASS I	Breathing circuit set, coaxial recalled by Hamilton Medical AG	Hamilton Medical AG	Device Malfunction	Nationwide
24 Jun 2026Device	CLASS I	Giraffe Stand-alone Infant Resuscitation System recalled by Datex-Ohmeda	Datex-Ohmeda	Device Malfunction	WI