Z-1657-2022Class I

Philips OmniLab Advanced+, Rx Only. To provide noninvasive ventilation support for patients with obstructive...

Name: Z-1657-2022 Philips OmniLab Advanced+, Rx Only. To provide noninvasive ventilation support for patients with obstructive...
Creator: Philips Respironics, Inc.
Published: 2022-08-26
License: https://open.fda.gov/license/

Respironics, Inc. / initiated 2022-08-26 / Open, Classified / root cause: manufacturing process

FDA source

Philips Respironics, Inc. began a recall of Philips OmniLab Advanced+, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory... on 2022-08-26. FDA classified it as Class I and gives the reason as "Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1657-2022
Classification: Class I
Status: Open, Classified
Initiated: 2022-08-26
Posted: 2022-09-09
Recalling firm: Respironics, Inc.
Product: Philips OmniLab Advanced+, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
Product code: MNS Ventilator, Continuous, Non-Life-Supporting
Reason for recall: Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
Root cause tag: manufacturing process
FDA root cause: Process control
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].
Quantity in commerce: 85 units
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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1657-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1654-2022	Class I	Ongoing	Voluntary: Firm initiated	2022-09-14	2022-09-08
Z-1655-2022	Class I	Ongoing	Voluntary: Firm initiated	2022-09-14	2022-09-08
Z-1656-2022	Class I	Ongoing	Voluntary: Firm initiated	2022-09-14	2022-09-08
Z-1657-2022	Class I	Ongoing	Voluntary: Firm initiated	2022-09-14	2022-09-08
Z-1658-2022	Class I	Ongoing	Voluntary: Firm initiated	2022-09-14	2022-09-08
Z-1659-2022	Class I	Ongoing	Voluntary: Firm initiated	2022-09-14	2022-09-08

Product code MNS

K090248Class IIBIPAP AutosvRespironics Inc., Sleep & Home Respiratory Group / cleared 2009-03-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)