Philips Respironics recallZ-0662-2022 · Respironics California, LLC · initiated Jan 24, 2022

Why it was recalled

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 root cause category: Process control

What the company is doing

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

Recall details

Recall number

Z-0662-2022

Status

Open, Classified

Initiated by the company

Jan 24, 2022

Posted by the FDA

Feb 25, 2022

Recalling firm

Respironics California, LLC

Quantity

16 systems

Product code

MNT

FDA submissions

K102985

Distribution

U.S.: AR, CA, FL, GA, IN, LA, MD, MO, NY, PA, SC, TN and TX. O.U.S. N/A

Product description

Philips Respironics V60 Ventilator Part Number 1053617

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• Philips Respironics V60

  Respironics California, Inc. · Ventilator, Continuous, Minimal Ventilatory Support,Facility Use
  3 recalls30 deaths13,525 reports

Product lines

• Philips RespironicsRespironics California, Inc. · 3 models · 13,623 reports · 3 recalls