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A-Series BiPAP A 40, A-Series BiPAP A30 Continuous… recallZ-1958-2021 · Philips Respironics, Inc. · initiated Jun 14, 2021

Class I Open, Classified All recalls posted in July 2021

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

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 root cause category: Device Design

What the company is doing

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.

Recall details

Recall number
Z-1958-2021
Recall class
Class I (most serious)
Status
Open, Classified
Initiated by the company
Jun 14, 2021
Posted by the FDA
Jul 15, 2021
Recalling firm
Philips Respironics, Inc.
Quantity
72665
Product code
MNS
FDA submissions
K113053, K121623
Distribution
Worldwide distribution including US Nationwide, Argentina, Australia, Brazil, Canada, China, France, Germany, Italy, Japan, Korea, and Latin America.

Product description

A-Series BiPAP A 40, A-Series BiPAP A30 Continuous Ventilator, Non-life Supporting

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

All Devices manufactured before 26 April 2021, All device serial numbers.  Material Numbers 1076492 1076493 1076495 1076538 1076539 1076565 1076566 1076579 1076580 1076583 1076584 1076586 1078226 1078297 1104171 1111168 1111169 1111170 1111171 1111172 1111173 1111174 1111175 1111176 1111177 1116156 1122129 1140798 1140799 1111170S 1111170-S AR1111169 BR1076493 BR1076566 BR1111169 CN1076493 CN1076566 CN1111169 GB-SPK0011 GB-SPK0012 IT1111169 LA1076493 LA1076566 R1076495 R1111169 R1111177 R1116156 1104170 R1111175 RBR1111169 U1116156 1038916 1038917 1040716 1044114 1044235 1038987 1040717 1068942 1068943 1042900 1042901 1042903 1042904 1042906 1042907 1044288 1044289 1040718 1067255 1029744 1029750 1029756 1029757 1029758 1029759 AU1029756 CA1029756 CA1029759 LA1029756 1030075 1055770 1055813

Other devices under the same FDA submission

22 devices cleared under K113053, K121623 — the recall does not name any of them by identifier. 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 88071).

Sources and updates

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