Skip to content

BiPAP A30 recallZ-1654-2022 · Philips Respironics, Inc. · initiated Aug 26, 2022

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Philips Respironics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Process control

What the company is doing

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].

Recall details

Recall number
Z-1654-2022
Status
Open, Classified
Initiated by the company
Aug 26, 2022
Posted by the FDA
Sep 9, 2022
Recalling firm
Philips Respironics, Inc.
Quantity
146 units ***updated January 2024*** 30 additional units
Product code
MNS
FDA submissions
K113053
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 description

Philips BiPAP A30, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.

Code information (models, lots, serial numbers)

Show the full code information (3k characters)

UDI-DI:606959042667, 606959042681, 606959042698, 606959042728, 606959067585, 606959067530; Model No.: 1109581, 1109582, 1109585, 1109588, 1109589, 1109590, 1109594, 1109596, 1109598, 1109601, 1111124, 1111150, 1111155, 1111169, 1111177, 1111178, 1116153, 1116156, CN1111143, CN1111169, R1111124, R1111177; Serial No.: N287725308B25, N28870219ADAE, N288702267F31, N2887023003DF, N288702473A68, N28870248C29F, N2887025723B0, N28870279F97E, N28870300736B, N2887030162E2, N2887030341F0, N288703153D1E, N288703341F27, N28870339C4C2, N288703423719, N2887034989CA, N288703533F48, N288710382694, N28871040E7D4, N28871042C4C6, N28871043D54F, N28871045B079, N28871047936B, N288710486B9C, N28872243453A, N28872424B38C, N28872434AA54, N30471136FB91, N304711485FE7, N30471153F8EC, N30471195347A, N30471199FE16, N3047120278B9, N304754069AA8, N30475435825B, N304754394837, N30475443AA65, N30475445CF53, N3047544814B6, N306144680873, N30614484580F, N306146006553, N3061460174DA, N306146024641, N3061460357C8, N3061460532FE, N3061461619BD, N30614661200A, N3061467139D2, N3061469380D0, N3061471314CC, N3061473453C3, N306147376158, N30614793DA0C, N30614795BF3A, N306148142AB4, N306148336DBB, N30614918BA04, N306149333767, N30614983D3CF, N306150028C23, N306150218D08, N288885978931, N28888599604F, N28888601D47B, N28888602E6E0, N28888605925F, N28888606A0C4, N288886095833, N28888611CDA3, N28888613EEB1, N28888617A895, N290848821182, N2908488657A6, N29084889AF51, N290848964E7E, N290848975FF7, N29084900A68C, N29118378D6CD, N29118379C744, N29118381C8C4, N29118382FA5F, N29118383EBD6, N291183849F69, N291183858EE0, N291183885505, N29118390C095, N29118391D11C, N29118392E387, N29118393F20E, N2911839486B1, N291183959738, N29118380D94D, N29118387ADF2, N29118396A5A3, N2874293301D1, N287429470AFD, N28742976311C, N290952904FCD, N290952915E44, N290952926CDF, N290952937D56, N2909529409E9, N290952951860, N290952962AFB, N290952973B72, N29095298C385, N29095299D20C, N29095300C209, N29095301D380, N29095302E11B, N29095303F092, N2909530595A4, N29095306A73F, N29095307B6B6, N290953084E41, N290953095FC8, N29095310DBD1, N29095311CA58, N29095312F8C3, N29095313E94A, N290953149DF5, N290953158C7C, N29095316BEE7, N290953185799, N290953194610, N29095320F1B9, N29095321E030, N29095322D2AB, N29095323C322, N29095324B79D, N29095325A614, N29095326948F, N290953278506, N290953287DF1, N290953296C78, N29095330E861, N29095331F9E8, N29095332CB73, N29095333DAFA, N29095334AE45, N29095335BFCC, N290953368D57, N290953379CDE, N290953386429, N2909533975A0; ***updated Jan 2024***N30471136FB91, N304711485FE7, N30471153F8EC, N30471195347A, N30471199FE16, N3047120278B9, N304754069AA8, N30475435825B, N304754394837, N30475443AA65, N30475445CF53, N3047544814B6, N306144680873, N30614484580F, N306146006553, N3061460174DA, N306146024641, N3061460357C8, N3061460532FE, N3061461619BD, N3061467139D2, N3061469380D0, N3061471314CC, N3061473453C3, N30614795BF3A, N306148142AB4, N306149333767, N30614983D3CF, N306150028C23, N306150218D08;

Devices named in this recall

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

Product lines

Other devices under the same FDA submission

18 devices cleared under K113053 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 90695).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page