Device recall: Philips BiPAP A30, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea…
Class I FDA enforcement event 90695. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
Class I, in the words of FDA
a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death
Philips Respironics, Inc. started this device recall on 26 Aug 2022. The firm address in the FDA record is in Murrysville, PA. FDA put the recall in Class I. FDA event 90695 has 6 product records. The first FDA enforcement report date is 14 Sep 2022. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
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:…
Recalling firm
Philips Respironics, Inc., Murrysville, PA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
6 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1654-2022 | Philips BiPAP A30, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency. | 146 units ***updated January 2024*** 30 additional units | Class I | Ongoing | 14 Sep 2022 |
| Z-1655-2022 | Philips BiPAP A40, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency. | 1,091 units ***updated Jan 2024*** additional 323 units | Class I | Ongoing | 14 Sep 2022 |
| Z-1656-2022 | Philips BiPAP V30 Auto, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency. | 295 units | Class I | Ongoing | 14 Sep 2022 |
| Z-1657-2022 | Philips OmniLab Advanced+, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency. | 85 units | Class I | Ongoing | 14 Sep 2022 |
| Z-1658-2022 | Philips OmniLab Advanced+ Intl (Flow Gen), Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency. | 34 units ***updated January 2024 *** additional 3 units | Class I | Ongoing | 14 Sep 2022 |
| Z-1659-2022 | 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. | 8 units | Class I | Ongoing | 14 Sep 2022 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class I: The highest of the three FDA recall classes.
The event in context
- Device events that started in 2022
- 839
- Share of these events in Class I
- 8%
- Product records in this event
- 6Median of the firm: 3
- Events of the firm on the register
- 26
Other events of the firm
Official channels
- FDA enforcement report Z-1654-2022The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 90695. https://recallregister.com/fda/i/90695/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this 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:…
- What quantity of product is in FDA event 90695?
- The event has 6 product records. The first record gives this quantity:
146 units ***updated January 2024*** 30 additional units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2022 have the same class?
- 8% of the 839 device events that started in 2022 are in Class I.