Reported Jan 15, 2014 · Terminated

Puritan Bennett 840 ventilator systems software part number 4-070212-85, revision AB-AG. The intended use of the…

Covidien

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Covidien · 6135 Gunbarrel Ave · Boulder, CO · 80301-3214

Is this the product you have?

  • Puritan Bennett 840 ventilator systems software part number 4-070212-85, revision AB-AG. The intended use of the product is to provide mechanical ventilation to patients.
Lot codes and dates
  • Software Part number 4-070212-85, revision AB-AG
Amount recalled
16,923 US, 39,372 OUS

Where it was sold

Why it was recalled

Stop using this product now

Covidien is conducting a voluntary field corrective action on Puritan Bennett 840 ventilator systems with certain software revisions in response to customer reports of ventilator diagnostic code XB0069 in which the device stops mechanical ventilation due to a software error.

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Nov 29, 2016 · Data as of Sep 19, 5:27 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.