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U.S. Department of Health and Human Services

Class 1 Device Recall Respironics Model V60 Ventilator

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  Class 1 Device Recall Respironics Model V60 Ventilator see related information
Date Initiated by Firm January 24, 2022
Date Posted February 25, 2022
Recall Status1 Open3, Classified
Recall Number Z-0662-2022
Recall Event ID 89490
510(K)Number K102985  
Product Classification Ventilator, continuous, minimal ventilatory support, facility use - Product Code MNT
Product Philips Respironics V60 Ventilator Part Number 1053617
Code Information The Component of the Ventilators that is impacted is: N 1034132 BRACKET, CAPACITOR,MOTOR DRIVER PCB  Model V60 Part Number: 1053617 Serial Numbers/UDI Code: MX0016593 / (01)00884838020054(21)MX0016593 MX0016797 / (01)00884838020054(21)MX0016797 MX0016824 / (01)00884838020054(21)MX0016824 MX0016827 / (01)00884838020054(21)MX0016827 MX0016830 / (01)00884838020054(21)MX0016830 MX0016839 / (01)00884838020054(21)MX0016839 MX0016840 / (01)00884838020054(21)MX0016840 MX0016841 / (01)00884838020054(21)MX0016841 MX0016845 (01)00884838020054(21)MX0016845 MX0016853 (01)00884838020054(21)MX0016853 MX0016867 (01)00884838020054(21)MX0016867 MX0016870 (01)00884838020054(21)MX0016870 MX0016871 (01)00884838020054(21)MX0016871 MX0016872 (01)00884838020054(21)MX0016872 MX0016875 (01)00884838020054(21)MX0016875 MX0016878 (01)00884838020054(21)MX0016878  
Recalling Firm/
Manufacturer		 Respironics California, LLC
2271 Cosmos Ct
Carlsbad CA 92011-1517
For Additional Information Contact Philips Customer Service
800-722-9377
Manufacturer Reason
for Recall		 A limited number of ventilators were assembled with expired adhesive. If the adhesive fails, a bracket may become loose and potentially damage the capacitors, which could cause the ventilator to stop providing ventilation to the patient. This failure may either activate both visual and audible alarms, or it may not sound or display an alarm (a silent shutdown).
FDA Determined
Cause 2		 Process control
Action On 01/24/2022, the firm sent an "URGENT MEDICAL DEVICE CORRECTION" Letter via priority mail to customer informing them that a limited number of ventilators have been identified to have an internal component assembled with expired adhesive. There is a possibility that two failures may occur simultaneously activated by adhesive failure and if the component that the adhesive is assembled to also fails. The results of the failures could lead to: 1) The ventilator ceases to operate, activating both visual and audible alarms, or 2) The ventilator ceases to operate and does not activate either visual or audible alarm causing a "silent shutdown". Customers are instructed to: 1) Compare the serial numbers of their device(s) to Attachment A: List of Impacted Serial Numbers to determine if the ventilator is impacted. Device serial number information can be located at the rear of the ventilator. Alternatively, the serial number of the ventilator may be viewed from the display while the ventilators is operation. Select the Menu tab at the bottom of the screen then select Vent Info. 2) Additional actions that should be taken by the customer: -It is not necessary to remove affected ventilators from service. -The ventilators have a remote alarm system capability that allows the ventilators to be connected to a remote alarm system. The Recall Firm is recommending to utilize a remote alarm. The remote alarm will provide a backup warning even if the ventilator's primary alarm system does not alarm. Directions for connecting a remote alarm system can be found in Section B-5: "Remote Alarm Port" of the Operation's Manual. -It is important to follow directions in the Operation's Manual and the Urgent Medical Device Correction Letter to further reduce any risk associated with this potential failure. -From the Operator's Manual: 1. Provide external oxygen monitoring to minimize patient risk in case of O2 supply loss or ventilator failure. 2. Promptly respond to all low
Quantity in Commerce 16 systems
Distribution U.S.: AR, CA, FL, GA, IN, LA, MD, MO, NY, PA, SC, TN and TX. O.U.S. N/A
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 Inc.
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