BEUDAMED
    FDA Recall Open, Classified

    Philips OmniLab Advanced+ Intl (Flow Gen), Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.

    Recall: Z-1658-2022 · Initiated August 26, 2022

    Recall

    Recall Number
    Z-1658-2022
    Event Number
    90695
    Firm
    Philips Respironics, Inc.
    FEI Number
    2518422
    Product Code
    MNS
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    August 26, 2022
    Posted
    September 9, 2022
    Address
    1001 Murry Ridge Ln, Murrysville, PA, 15668-8517

    Description

    Philips OmniLab Advanced+ Intl (Flow Gen), Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.

    Reason

    Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.

    Action

    The firm distributed an "URGENT Medical Device Recall" letter to customers dated 8/26/2022 via mail. The notification informs customers that certain BiPAP V30 Auto and OmniLab Advanced+ units distributed in the US have the potential to off-gas harmful chemicals and structural failure of the device motor due to nonconforming material used in the assembly. Patients are to stop using the recalled devices and consult with their physician to determine the most appropriate options for continued treatment. Customers are asked to locate all affected devices and immediately stop use and remove them from service. Affected units are to be replaced by non-impacted units if it is being used by a patient. The provided recall notification needs to be distributed to all who must be aware within your organization or any organization where the units may have been transferred. Urgent Medical Device Response Forms provided must be completed and returned via email to [email protected]. Philips is taking action by replacing the affected motor assemblies at the same time as they are remediating the PE-PUR Foam in recalled units. Philips will arrange for shipment of devices for repair and return. Customers with any questions are to contact Philips Respironics Recall Support at 1-877-387-3311 or email [email protected].

    Distribution

    Domestic: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, TN, TX, VA, VT, WA, WI, WV, & WY. Foreign: Australia, Austria, Bangladesh, Brazil, Canada, China, Denmark, Egypt, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Japan, Malaysia, Mexico, Myanmar, Philippines, Qatar, Serbia, Singapore, Taiwan, Thailand, Turkey, UAE, & UK.

    Quantity

    34 units ***updated January 2024 *** additional 3 units