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U.S. Department of Health and Human Services

Class 1 Device Recall BiPAP V30

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  Class 1 Device Recall BiPAP V30 see related information
Date Initiated by Firm March 26, 2024
Date Posted May 24, 2024
Recall Status1 Open3, Classified
Recall Number Z-1812-2024
Recall Event ID 94475
Product Classification Ventilator, continuous, non-life-supporting - Product Code MNS
Product BiPAP V30 Auto Ventilator, Part Number 1111178
Code Information UDI-DI 00606959049635 Serial Numbers N2068642229E4 N206864244CD2 N206864255D5B N206864277E49 N2068642886BE N206864299737 N2068643102A7 N20686432303C N2068643321B5 N20686434550A N206864354483 N206864367618 N206864376791 N206864389F66 N206864398EEF N206864405E26 N206864414FAF N206864427D34 N206864441802 N20686445098B N206864463B10 N206864472A99 N20686448D26E N20686449C3E7 N2068645047FE N206864515677 N2068645264EC N206864537565 N2068645401DA N206864551053 N2068645622C8 N206864573341 N20686458CBB6 N206864606D96 N206864617C1F N206864624E84 N206864635F0D N206864653A3B N2068646608A0 N2070799636A7 N20708029041F N20708103C229 N20708105A71F N2070811974AB N20708120C302 N20708137AE65 N20708141865B N20708147E36D N20713207A038 N20713212EE4D N207132184117 N20713222C425 N20713232DDFD N2071323872A7 N20713245E44A N207132582677 N20713270998F N207132810BCE N2071329445BB N2071329666A9 N207132977720 N207132988FD7 N207132999E5E N20713309139A N20713314D1A7 N207133190A42 N20713327C954 N207133328721 N2071333396A8 N2071335695D5 N20713363E810 N2071337594FE N20713377B7EC N2071338625AD N207133972DFC N207134088E16 N207134099F9F N207134145DA2 N207134212067 N2071342654D8 N207134375C89 N20713442462C N2071344357A5 N207134507CE6 N207134726C44 N2071347518FB N207134762A60 N20713478C31E N207134859B33 N205345571B7A N20534558E38D N20534559F204 N2053456045AD N2053456266BF N205345637736 N205345640389 N205345651200 N20534566209B N205345673112 N20534568C9E5 N20534569D86C N205345705C75 N205345714DFC N205345727F67 N205345736EEE N205345741A51 N205345750BD8 N206864266FC0 N20686430132E N206864436CBD N206864671929 N20686470744E N2068647165C7 N20686472575C N2068647346D5 N20686474326A N206864761178 N2068647700F1 N20686478F806 N20686479E98F N20686482D494 N20686483C51D N20686484B1A2 N20686485A02B N2068648692B0 N206864878339 N206864887BCE N20713231EF66 N207132955432 N207133019FD2 N207134740972 N207134773BE9 N20713479D297 N205345615424 N20686469F057 N20686480F786 N207082010E5F N20713263B2CC 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Recalling Firm/
Manufacturer
Philips Respironics, Inc.
1001 Murry Ridge Ln
Murrysville PA 15668-8517
For Additional Information Contact Philips Customer Service
800-345-6443
Manufacturer Reason
for Recall
Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death in the most vulnerable patients.
FDA Determined
Cause 2
Device Design
Action The firm notified customers via mailed "URGENT Medical Device Recall" notice on March 26, 2024. The notice described the product, problem and actions to be taken. The firm reminded customers to refer to the user manual and to perform a clinical assessment prior to placing a patient on the ventilator to ensure that: 1. The device is appropriately set for patient requirements. 2. Alternate ventilation equipment is available. 3. Alternative monitoring (such as alarming Pulse Oximeter or Respiratory) is used where appropriate. Depending on the level of ventilatory support required, customers were advised to place patients on an alternate source of ventilation. Philips is currently investigating the issue. If you need any further information or support concerning this issue, please contact your local Philips Respironics representative: 1-800-345-6443, prompts 4, 5 or email at respironics.clinical@philips.com. A second "URGENT Medical Device Recall" notice was distributed to customers on June 12, 2024. In the notice customers were provided additional guidance on how to operate the device when a Ventilator Inoperative Alarm occurs and how to perform an optional hard reboot of their device that will temporarily restore functionality.
Quantity in Commerce 5,958 US; None OUS
Distribution US Nationwide distribution and OUS International distribution to NM, PR, and GU.
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.
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