Drug recall
Respironics RP-Touch Screen, V60/V680 Ventilator Serviced with Touchscreen RP Kit 453561511951 containing a…
FDA recall event 83980 · Class II · Respironics California, LLC
Key facts
| Event ID | 83980 |
|---|---|
| Recall numbers | Z-1152-2020, Z-1153-2020, Z-1154-2020, Z-1155-2020 |
| Recalling firm | Respironics California, LLC |
| Product type | Devices |
| Products | Respironics RP-Touch Screen, V60/V680 Ventilator Serviced with Touchscreen RP Kit 453561511951 containing a touchscreen labeled as raw part number 1132318 Revision C, Respironics RP-UI Assy, V60 Ventilators User Interface RP-Kits, REF/P/N: 453561528931, 453561528941, 453561536451, 453561536461, Respironics V60 Ventilator, Service # 850008, REF: 1053613, 1053614, 1053617, 1053614, Respironics V680 Ventilator, Service # 850011, (OUS Only) |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Ventilator touchscreen may become frozen and fail to respond to touch commands. If a patient requires a change in therapy, there is no warning associated with an unresponsive touchcreen, and therefore…, Ventilator touchscreen may become frozen and fail to respond to touch commands. If a patient requires a change in therapy, there is no warning associated with an unresponsive touchscreen, and… |
| Initiation date | Sep 11, 2019 |
| Report date | Feb 19, 2020 |
| City | Carlsbad |
| State | CA |
| Country | United States |
| FEI number | 3002470603 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: