Class 2 Device Recall V60 Ventilator

• Date Initiated by Firm: September 11, 2019
• Create Date: March 02, 2020
• Recall Status: Open, Classified
• Recall Number: Z-1152-2020
• Recall Event ID: 83980
• 510(K)Number: K082660
• Product Classification: Ventilator, continuous, minimal ventilatory support, facility use - Product Code MNT
• Product: Respironics V60 Ventilator, Service # 850008, REF: 1053613, 1053614, 1053617, 1053614
• Code Information: Serial Numbers: 100005249 100254792 100255723 100255865 100256311 100256502 100256609 100256781 100256875 100257173 100257312 100257583 100257698 100258034 100258360 100258513 100258809 100259082 100259249 100259633 100259878 100260186 100260534 100260846 100261115 100261278 100261538 100261743 100262170 100262417 100262531 100262627 100262821 100007779 100254793 100255724 100255866 100256312 100256503 100256610 100256782 100256876 100257174 100257313 100257584 100257699 100258035 100258361 100258514 100258810 100259083 100259250 100259634 100259879 100260231 100260535 100260847 100261117 100261279 100261539 100261744 100262171 100262418 100262532 100262628 100262822 100007982 100254977 100255725 100255965 100256313 100256504 100256611 100256783 100256877 100257175 100257314 100257585 100257800 100258159 100258362 100258553 100258811 100259085 100259251 100259635 100259880 100260233 100260537 100260849 100261120 100261302 100261540 100261745 100262172 100262419 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• Recalling Firm/ Manufacturer: Respironics California, LLC; 2271 Cosmos Ct; Carlsbad CA 92011-1517
• For Additional Information Contact: 760-918-7300
• Manufacturer 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 touchscreen, 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.
• FDA Determined Cause: Other
• Action: On 09/26/19, Urgent Medical Device Correction Field Safety Notices were mailed to customers. Firm is asking customers to follow the Action to be Taken by Customer/User section of the Medical Device Correction notification/Field Safety Notice (Ventilator): 1) If in use on a patient, continue to use the ventilator if an alternative non-invasive ventilator is not available. 2) If a touchscreen failure is detected, disconnect the patient and immediately start ventilation with an alternate device. Contact your local customer service representative to report the failure. 3) To minimize the risk of patient injury, operate the Ventilator as defined in the operator's manual and promptly attend to all alarms presented by the ventilator. 4) As recommended in the operator's manual, use an external 02 monitor/analyzer and set the alarm thresholds appropriately. 5) As recommended in the operator's manual, have an alternative means of ventilation available whenever the ventilator is in use. 6) Acknowledge receipt of this notification. Firm is asking customers to follow the Action to be Taken by Customer/User section of the Medical Device Correction notification/Field Safety Notice (User Interface RP-Kits): 1) If the affected kit is installed on a ventilator and in use on a patient, continue to use the ventilator if an alternative non-invasive ventilator is not available. 2) If the affected kit is installed on a ventilator, document the serial number of the ventilator and the serial number of the affected User Interface Assembly it contained, on the attached Acknowledgement and Receipt Form. 3) If the affected devices could not be found or linked to a ventilator at your site, please indicate this within in the detail section provided on the form, 4) Return the completed and signed Acknowledgement and Receipt Form. Firm is asking customers to follow the Action to be Taken by Customer/User section of the Medical Device Correction notification/Field Safety Notice (Tou
• Quantity in Commerce: 2851
• Distribution: 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = MNT and Original Applicant = RESPIRONICS CALIFORNIA, INC.