Philips OmniLab Advanced + with Heated Tube Humidifier, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
- Company
- Philips Respironics, Inc.
- Recall Initiated
- August 26, 2022
- Posted
- September 9, 2022
- Recall Number
- Z-1659-2022
- Quantity
- 8 units
- Firm Location
- Murrysville, PA
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.
Lot / Code Info
UDI-DI: 606959067837, 606959068001; Model No.: 1111124, R1111124; Serial No. L29084645477C, L303986771E8D, L303987043BC2, L3039871356A5, L30398768A57E, L303987892EE7, L30398795FD53, L30398849CD80
Root Cause
Process control
Action Taken
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 pms.fac@philips.com. 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 pms.fac@philips.com.