Puritan Bennett 840 Ventilator Software Recall for Diagnostic Code XB0069
Covidien is recalling Puritan Bennett 840 ventilators with specific software revisions because a software error causes the device to stop mechanical ventilation.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device that stops providing mechanical ventilation, which is a risk-of-harm product where injury has not yet been reported in the source text.
Plain-English summary
Covidien is conducting a voluntary field corrective action for Puritan Bennett 840 ventilator systems. The recall affects units with software part number 4-070212-85, revisions AB through AG. The intended use of these devices is to provide mechanical ventilation to patients.
The recall is in response to customer reports of ventilator diagnostic code XB0069. This diagnostic code indicates that the device stops mechanical ventilation due to a software error. The affected units were distributed worldwide, including nationwide in the United States and in numerous international locations.
Healthcare providers and consumers should check their Puritan Bennett 840 ventilator systems for the specific software part number and revision listed in the recall. If the device matches the affected software revisions, users should contact the manufacturer for instructions on the corrective action.
The recalled product
- Product
- 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.
- Manufacturer
- Covidien
- Category
- Medical Device — Ventilator
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Software Part number 4-070212-85
- revision AB-AG
Distribution
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