Philips OmniLab Advanced+, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apne
Summary
The FDA issued a Class I for Philips OmniLab Advanced+, Rx Only. To provide noninvasive ventilation support by Philips Respironics, Inc.. Reason: Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs..
Details
Source
Device Recall
External ID
Z-1657-2022
Action Date
2022-09-14
Status
Ongoing
Category
device
Product Description
Philips OmniLab Advanced+, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
Lot/Code Info: UDI-DI: 606959028791; Model No.: 1109581; Serial No. L28664716B714, L28664717A69D, L286647185E6A, L286647194FE3, L28664720F84A, L28664721E9C3, L28664722DB58, L28664723CAD1, L28664724BE6E, L28870984130F, L288709850286, L28870986301D, L288709872194, L28870988D963, L28870989C8EA, L288709904CF3, L288709915D7A, L288709926FE1, L288709937E68, L288709940AD7, L288709951B5E, L2887099629C5, L28870997384C, L28870998C0BB, L28870999D132, L288710001B4E, L288710010AC7, L28871002385C, L2887100329D5, L288710045D6A, L288710054CE3, L288710067E78, L288710076FF1, L288710089706, L28871009868F, L288710100296, L288710122184, L28871013300D, L2887101444B2, L28871015553B, L2887101667A0, L288710177629, L288710188EDE, L288710199F57, L2887102028FE, L288710213977, L288710220BEC, L288710231A65, L288710246EDA, L288710257F53, L288710264DC8, L288710275C41, L28871028A4B6, L28871029B53F, L288710303126, L2887103120AF, L288710321234, L2887103303BD, L290846327ECB, L290846336F42, L290846341BFD, L290846350A74, L2908463638EF, L29084638D191, L29084639C018, L2908464010D1, L290846410158, L2908464233C3, L29084643224A, L2908464456F5, L2908464675E7, L29084647646E, L290846489C99, L290846498D10, L290846500909, L290846511880, L290846522A1B, L290846533B92, L290846544F2D, L290846555EA4, L290846566C3F, L303986996DE3, L30398708F1AE, L3039884141C8, L304097046ACC
Quantity Affected: 85 units
Reason for Recall
Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-08-26
Company
Murrysville, PA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 134 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Philips Respironics, Inc. has 74 FDA actions in our database, including 74 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Philips Respironics, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Philips Respironics, Inc. have FDA actions?
Philips Respironics, Inc. has 74 FDA actions in our database, including 74 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1657-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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