Philips Respironics V60 Ventilator Part Number 1053617
Check against the official notice below — it lists the full affected range.
A limited number of Philips Respironics V60 ventilators (part number 1053617) were assembled with expired adhesive that could fail, causing a bracket to become loose and potentially damage internal capacitors. If this occurs, the ventilator could stop providing ventilation to the patient. The failure may trigger both visual and audible alarms to alert users, or in some cases may occur silently without any alarm.
Sixteen affected ventilators with specific serial numbers (MX0016593, MX0016797, MX0016824, MX0016827, MX0016830, MX0016839, MX0016840, MX0016841, MX0016845, MX0016853, MX0016867, MX0016870, MX0016871, MX0016872, MX0016875, and MX0016878) were distributed in Arkansas, California, Florida, Georgia, Indiana, Louisiana, Maryland, Missouri, New York, Pennsylvania, South Carolina, Tennessee, and Texas. The source document does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
A limited number of ventilators were assembled with expired adhesive. If the adhesive fails, a bracket may become loose and potentially damage the capacitors, which could cause the ventilator to stop providing ventilation to the patient. This failure may either activate both visual and audible alarms, or it may not sound or display an alarm (a silent shutdown).
Reason for recall: A limited number of ventilators were assembled with expired adhesive. If the adhesive fails, a bracket may become loose and potentially damage the capacitors, which could cause the ventilator to stop providing ventilation to the patient. This failure may either activate both visual and audible alarms, or it may not sound or display an alarm (a silent shutdown). Distribution: U.S.: AR, CA, FL, GA, IN, LA, MD, MO, NY, PA, SC, TN and TX. O.U.S. N/A Quantity: 16 systems Lot/code info: The Component of the Ventilators that is impacted is: N 1034132 BRACKET, CAPACITOR,MOTOR DRIVER PCB Model V60 Part Number: 1053617 Serial Numbers/UDI Code: MX0016593 / (01)00884838020054(21)MX0016593 MX0016797 / (01)00884838020054(21)MX0016797 MX0016824 / (01)00884838020054(21)MX0016824 MX0016827 / (01)00884838020054(21)MX0016827 MX0016830 / (01)00884838020054(21)MX0016830 MX0016839 / (01)00884838020054(21)MX0016839 MX0016840 / (01)00884838020054(21)MX0016840 MX0016841 / (01)00884838020054(21)MX0016841 MX0016845 (01)00884838020054(21)MX0016845 MX0016853 (01)00884838020054(21)MX0016853 MX0016867 (01)00884838020054(21)MX0016867 MX0016870 (01)00884838020054(21)MX0016870 MX0016871 (01)00884838020054(21)MX0016871 MX0016872 (01)00884838020054(21)MX0016872 MX0016875 (01)00884838020054(21)MX0016875 MX0016878 (01)00884838020054(21)MX0016878
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.