| Class 1 Device Recall Respironics Model V60 Plus Ventilator | |
Date Initiated by Firm | January 24, 2022 |
Date Posted | February 25, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0663-2022 |
Recall Event ID |
89490 |
510(K)Number | K102985 |
Product Classification |
Ventilator, continuous, minimal ventilatory support, facility use - Product Code MNT
|
Product | Philips Respironics V60 Plus Ventilator Part Number 1138747 |
Code Information |
The Component of the Ventilators that is impacted is: N 1034132 BRACKET, CAPACITOR,MOTOR DRIVER PCB Model V60 Part Number: 1138747 Serial Numbers/UDI Code: MX0016240/ (01)00884838090996(21)MX0016240 MX0016241/ (01)00884838090996(21)MX0016241 MX0016242/ (01)00884838090996(21)MX0016242 MX0016243/ (01)00884838090996(21)MX0016243 MX0016244/ (01)00884838090996(21)MX0016244 MX0016245/ (01)00884838090996(21)MX0016245 MX0016246/ (01)00884838090996(21)MX0016246 MX0016247/ (01)00884838090996(21)MX0016247 MX0016248/ (01)00884838090996(21)MX0016248 MX0016522/ (01)00884838090996(21)MX0016522 MX0016523/ (01)00884838090996(21)MX0016523 MX0016525/ (01)00884838090996(21)MX0016525 MX0016527/ (01)00884838090996(21)MX0016527 MX0016529/ (01)00884838090996(21)MX0016529 MX0016531/ (01)00884838090996(21)MX0016531 MX0016532/ (01)00884838090996(21)MX0016532 MX0016533/ (01)00884838090996(21)MX0016533 MX0016534/ (01)00884838090996(21)MX0016534 MX0016535/ (01)00884838090996(21)MX0016535 MX0016536/ (01)00884838090996(21)MX0016536 MX0016538/ (01)00884838090996(21)MX0016538 MX0016539/ (01)00884838090996(21)MX0016539 MX0016540/ (01)00884838090996(21)MX0016540 MX0016541/ (01)00884838090996(21)MX0016541 MX0016542/ (01)00884838090996(21)MX0016542 MX0016545/ (01)00884838090996(21)MX0016545 MX0016546/ (01)00884838090996(21)MX0016546 MX0016547/ (01)00884838090996(21)MX0016547 MX0016548/ (01)00884838090996(21)MX0016548 MX0016549/ (01)00884838090996(21)MX0016549 MX0016550/ (01)00884838090996(21)MX0016550 MX0016552/ (01)00884838090996(21)MX0016552 MX0016553/ (01)00884838090996(21)MX0016553 MX0016554/ (01)00884838090996(21)MX0016554 MX0016556/ (01)00884838090996(21)MX0016556 MX0016559/ (01)00884838090996(21)MX0016559 MX0016560/ (01)00884838090996(21)MX0016560 MX0016561/ (01)00884838090996(21)MX0016561 MX0016562/ (01)00884838090996(21)MX0016562 MX0016568/ (01)00884838090996(21)MX0016568 MX0016569/ (01)00884838090996(21)MX0016569 MX0016570/ (01)00884838090996(21)MX0016570 MX0016571/ 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(01)00884838090996(21)MX0017914 MX0018141/ (01)00884838090996(21)MX0018141 MX0018143/ (01)00884838090996(21)MX0018143 MX0018144/ (01)00884838090996(21)MX0018144 MX0018148/ (01)00884838090996(21)MX0018148 MX0018150/ (01)00884838090996(21)MX0018150 MX0018151/ (01)00884838090996(21)MX0018151 MX0018154/ (01)00884838090996(21)MX0018154 MX0018155/ (01)00884838090996(21)MX0018155 MX0018159/ (01)00884838090996(21)MX0018159 MX0018179/ (01)00884838090996(21)MX0018179 MX0018185/ (01)00884838090996(21)MX0018185 MX0018192/ (01)00884838090996(21)MX0018192 MX0018193/ (01)00884838090996(21)MX0018193 MX0018197/ (01)00884838090996(21)MX0018197 MX0018199/ (01)00884838090996(21)MX0018199 MX0018202/ (01)00884838090996(21)MX0018202 MX0018204/ (01)00884838090996(21)MX0018204 MX0018209/ (01)00884838090996(21)MX0018209 MX0018210/ (01)00884838090996(21)MX0018210 MX0018222/ (01)00884838090996(21)MX0018222 MX0018224/ (01)00884838090996(21)MX0018224 |
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 | 294 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 |
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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.
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510(K) Database | 510(K)s with Product Code = MNT
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