Recall Z-1622-2020 ยท MNT Continuous, Minimal Ventilatory Support, Facility Use Ventilator
Respironics California, LLC
Philips V60 Ventilators with Power Management PCBA part number 1055906
| Date | Mar 5, 2020 |
| Status | Open, Classified |
| Reason | Solder connection failure on Power Management printed circuit board assembly of ventilators may cause 1) Blower to lose power, spool down, and trigger visual and audible High Priority Check Vent alarm indicating a need for alternative ventilation, or 2) Intermittent connection may disrupt expected operation and trigger unexpected shutdown without alarm. Failures may lead to hypercarbia/hypoxemia |
| Root cause | Under Investigation by firm |
| Action | On 03/05/20 Urgent Medical Device Correction Field Safety Notices were mailed to customers. Customers were informed that it is not necessary to remove affected V60 ventilators from service due to the rarity of these failure modes. Customers were asked to do the following: From the Operator's Manual: 1. Use an external O2 monitor/analyzer and set the ventilator alarm thresholds appropriately. 2. Promptly attend to all alarms presented by the ventilator. 3. Ensure that an alternative means of ventilation is available whenever the ventilator is in use. Additional directions: 4. Follow the ab |
| Quantity | 23581 |
| Distribution | U.S.: CO, PA, AZ, OH, MT, AR, FL, NC, KS, IL, CA, HI, MD, SC, WY, OR, NY, NE, OK, MN, UT, ND, LA, IN, AL, AK, WV, GA, WI, MI, VA, NJ, TX, WA, SD, KY, TN, MS, MO, DE, MA, VT, CT, IA, NV, ID, ME, NM, DC, NH, VI, RI, PR. O.U.S.: Argentina, Australia, Austria, Bahrain, Belgium, Bolivia, Brazil, Canada, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082660 | V60 VENTILATOR, MODEL V8000 Respironics California, Inc., Jan 9, 2009 |