FDA (Devices) recall action 88987
The FDA (Devices) publishes a recall like this one as 16 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 16 pages.
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Covidien is recalling 278 Puritan Bennett 980 Series ventilators (model 980X3ENDIUU) due to a capacitor assembly error that may cause the device to become inoperable during patient use.
The Puritan Bennett 980 Series Ventilator may become inoperable due to a manufacturing defect in the internal capacitor assembly. A total of 278 units worldwide have been affected.
Covidien is recalling Puritan Bennett 980 Series Ventilators due to an assembly error in a capacitor. The defect may cause the ventilator to become inoperable during use.
Covidien LLC is recalling 278 units of the Puritan Bennett 980 Series Ventilator due to a manufacturing defect that may cause the device to become inoperable during clinical use.
Covidien is recalling Puritan Bennett 980 Series Ventilators (model 980X1ENAIQC) due to an incorrectly assembled capacitor that may cause the device to become inoperable. The recall involves 278 units distributed worldwide, including the US.
Covidien is recalling 278 Puritan Bennett 980 Series Ventilators due to a manufacturing error where a capacitor was assembled incorrectly, which may cause the device to become inoperable during use.
Puritan Bennett 980 Series Ventilators are recalled due to an assembly error in a capacitor that may cause the device to become inoperable during use. The recall affects 278 units.
Covidien is recalling 278 Puritan Bennett 980 Series Ventilators (Model 980X1ENDIPC) due to incorrect capacitor assembly that may cause the device to malfunction during use.
Covidien is recalling the Puritan Bennett 980 Series Ventilator due to incorrect capacitor assembly that may cause the device to become inoperable during patient use.
Covidien is recalling 278 Puritan Bennett 980 Series Ventilators worldwide due to incorrect capacitor assembly that may cause devices to become inoperable during patient use.
Covidien is recalling 278 Puritan Bennett 980 Series Ventilators due to an assembly error in a capacitor that may cause the device to become inoperable during use. This recall affects units worldwide and in the US.
Covidien Llc is recalling 278 Puritan Bennett 980 Series Ventilators due to a manufacturing assembly error where a capacitor may have been installed incorrectly, potentially causing device inoperability during use.
The Puritan Bennett 980 Series Ventilator is being recalled because a capacitor may be assembled incorrectly, which could cause the ventilator to stop working during use.
Puritan Bennett 980 Series Ventilators are recalled due to a capacitor assembly error that may cause the device to become inoperable during use. The recall affects 278 units distributed worldwide.
Covidien LLC is recalling 278 Puritan Bennett 980 Series Ventilators due to a capacitor assembly error that may cause the device to become inoperable during use. Affected devices were distributed worldwide with specific serial numbers targeted.
Covidien is recalling 278 Puritan Bennett 980 Series Ventilators worldwide due to an assembly error where a capacitor was incorrectly installed, potentially causing the device to become inoperable during use.