Class 1 Device Recall ASeries BiPAP Hybrid A30 (not marketed in US), ASeries BiPAP V30 Auto Continuous Ventilator

• Date Initiated by Firm: June 14, 2021
• Date Posted: July 15, 2021
• Recall Status: Open, Classified
• Recall Number: Z-1957-2021
• Recall Event ID: 88071
• 510(K)Number: K113053
• Product Classification: Ventilator, continuous, non-life-supporting - Product Code MNS
• Product: A-Series BiPAP Hybrid A30 (not marketed in US), A-Series BiPAP V30 Auto Continuous Ventilator, Minimum Ventilatory Support, Facility Use
• Code Information: All Devices manufactured before 26 April 2021, All device serial numbers. Material Numbers 1111181 1111182 1111178 1140184 1135427 1143671
• Recalling Firm/ Manufacturer: Philips Respironics, Inc.; 1001 Murry Ridge Ln; Murrysville PA 15668-8517
• For Additional Information Contact: 724-733-0200
• Manufacturer Reason for Recall: The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.
• FDA Determined Cause: Device Design
• Action: Urgent Medical Device Recall letters were sent to customers starting 6/14/21. 1. Do not stop or alter your prescribed therapy until you have talked to your physician. Your physician may evaluate if the benefit outweighs the risks. 2. If your physician determines that you must continue using this device, use an inline bacterial filter. Your Instructions for Use has guidance on installation. 3. Register your device on www.philips.com/src-update or call 1-877-907-7508. An updated URGENT: Medical Device Recall notification letter was issued on 11/16/21. 1. Do not stop or change ventilator use until you have talked to your health care provider. If patients requiring a ventilator for life-sustaining therapy have no alternate, or therapy disruption is unacceptable, the HCP may determine if the benefit of continued use of these ventilator devices outweighs the potential risks identified in the recall letter. 2. Talk to your HCP about using an inline bacterial filter to help filter out foam particles. Instructions for Use has guidance on installation. At this time, the FDA does not have evidence of the safety and effectiveness of a filter for mitigating the foam risks, and evaluation is ongoing. Filters will not reduce exposure to chemicals from the PE-PUR foam. Filters may increase air flow resistance and affect ventilator performance. Monitor for accumulation of foam debris in the filter or resistance-related problems in the breathing circuit after filter placement. 3. Report any problems with a device through the FDA MedWatch Voluntary Reporting Form. 4. Register your device on the recall website www.philips.com/src-update with your device Serial Number, or call 1-877-907-7508. Devices should be serviced only by qualified technicians. There are no user serviceable parts. Attempts to remove the sound abatement foam may render the device permanently inoperative. Devices damaged due to foam removal attempts will not be able to be remediated.
• Quantity in Commerce: 8047
• Distribution: Worldwide distribution including US Nationwide, Argentina, Australia, Brazil, Canada, China, France, Germany, Italy, Japan, Korea, and Latin America.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = MNS