Recall Z-0663-2022 ยท MNT Continuous, Minimal Ventilatory Support, Facility Use Ventilator
Respironics California, LLC
Philips Respironics V60 Plus Ventilator Part Number 1138747
| Date | Feb 25, 2022 (initiated Jan 24, 2022) |
| Status | Open, Classified |
| Reason | 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). |
| Root cause | Process control |
| Action | On 01/24/2022, the firm sent an "URGENT MEDICAL DEVICE CORRECTION" Letter via priority mail to customer informing them that a limited number of ventilators have been identified to have an internal component assembled with expired adhesive. There is a possibility that two failures may occur simultaneously activated by adhesive failure and if the component that the adhesive is assembled to also fails. The results of the failures could lead to: 1) The ventilator ceases to operate, activating both visual and audible alarms, or 2) The ventilator ceases to operate and does not activate either visu |
| Quantity | 294 systems |
| Distribution | U.S.: AR, CA, FL, GA, IN, LA, MD, MO, NY, PA, SC, TN and TX. O.U.S. N/A |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102985 | V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS Respironics, Inc., Apr 5, 2011 |