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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