Recall Z-1137-2021 ยท MNT Continuous, Minimal Ventilatory Support, Facility Use Ventilator
Respironics California, LLC
PHILIPS BATTERY, V60 14.4V, 11.0 Ah, 163 Wh, REF 1076374(1058272), LOT M94663-P1 - Product Usage: The ventilator is intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
| Date | Jan 6, 2021 |
| Status | Open, Classified |
| Reason | Due to unqualified "design verification" batteries being shipped to customers. |
| Root cause | Under Investigation by firm |
| Action | On 01/06/2021, the firm contacted via telephone calls and then on 01/29/2021 sent a follow-up "URGENT - Medical Device Removal" letter via priority mail to customers to inform them that the Recalling Firm shipped unqualified batteries to customers. These batteries are similar to production batteries but did complete final qualification testing. Potential hazards that may result, In a worst-case scenario, a battery failure could occur while in use on a patient during intra-hospital transport or when not connected to AC power. In both situations, the patient could lose ventilatory assistance a |
| Quantity | 94 batteries |
| Distribution | U.S. Nationwide distribution including in the states of FL, GA, IA, IA, IL. IL, MN, MO, NC, ND, OH, TX, TX and UT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082660 | V60 VENTILATOR, MODEL V8000 Respironics California, Inc., Jan 9, 2009 |