Recall Z-1155-2020— Respironics California, LLC
Class II · Ongoing
Class II FDA medical device recall by Respironics California, LLC, initiated 2019-09-11. It names one FDA 510(k) clearance: K082660. Product: Respironics V680 Ventilator, Service # 850011, (OUS Only). Reason: 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 the clinician would have no prior indication of a touchscreen failure and would be unable to change ventilator settings. The ventilator will continue to function at the predetermined and accepted settings required to support the patient. A delay in therapy adjustments may result in hypercarbia and/or hypoxemia..
- Recalling firm
- Respironics California, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2019-09-11
- Firm location
- Carlsbad, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Respironics V680 Ventilator, Service # 850011, (OUS Only)
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 the clinician would have no prior indication of a touchscreen failure and would be unable to change ventilator settings. The ventilator will continue to function at the predetermined and accepted settings required to support the patient. A delay in therapy adjustments may result in hypercarbia and/or hypoxemia.
Data sourced from openFDA. This site is unofficial and independent of the FDA.