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Respironics RP-Touch Screen, V60/V680 Ventilator Serviced with Touchscreen RP Kit 453561511951 co...

FDA Device Recall #Z-1154-2020 — Class II — September 11, 2019

Recall Summary

Recall Number Z-1154-2020
Classification Class II — Moderate risk
Date Initiated September 11, 2019
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Respironics California, LLC
Location Carlsbad, CA
Product Type Devices
Quantity 800

Product Description

Respironics RP-Touch Screen, V60/V680 Ventilator Serviced with Touchscreen RP Kit 453561511951 containing a touchscreen labeled as raw part number 1132318 Revision C

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.

Distribution Pattern

US Nationwide. OUS (Foreign): Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Finland, France, Germany, Greece, Hong Kong, Iceland, India, Indonesia, Israel, Italy, Malaysia, Mexico, Netherlands, Portugal, Singapore, South Africa, Spain, Sweden, United Arab Emirates, United Kingdom, Viet Nam, Oman, Philippines, Saudi Arabia, Taiwan, Turkey, Russian Federation, Argentina, Ecuador, Poland, Guatemala, Peru, Viet Nam

Lot / Code Information

Touchscreen Serial Number: 41088-1808-0001 to 0179, 41213-1809-0001 to 0200, 41305-1811-0001 to 0295, 41379-1812-0001 to 0250, 41379-1812-0251 to 0328, 41540-1813-0001 to 0195, 41633-1814-0001 to 0275, 41633-1814-0276 to 0285, 41724-1815-0001 to 0140, 41724-1815-0141 to 0183, 41838-1816-0001 to 0107, 41838-1816-0108 to 0165, 41930-1817-0001 to 0092, 42059-1818-0001 to 0150, 42059-1818-0151 to 0183, 42161-1819-0001 to 0117, 42161-1819-0118 to 0137, 42232-1820-0001 to 0130, 42232-1820-0131 to 0146, 42334-1822-0001 to 0134, 42334-1822-0135 to 0141, 42471-1823-0001 to 0143, 42471-1823-0144 to 0175, 42805-1828-0001 to 0138

Other Recalls from Respironics California, LLC

Recall # Classification Product Date
Z-0909-2022 Class I Philips Respironics V680 Ventilator (All Models... Feb 28, 2022
Z-0908-2022 Class I Philips Respironics V60 Plus Ventilator (All Mo... Feb 28, 2022
Z-0907-2022 Class I Philips Respironics V60 Ventilator (All Models,... Feb 28, 2022
Z-0662-2022 Class I Philips Respironics V60 Ventilator Part Number ... Jan 24, 2022
Z-0663-2022 Class I Philips Respironics V60 Plus Ventilator Part Nu... Jan 24, 2022

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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