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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "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…"
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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