Severity
Critical
CriticalClass IOngoing
FDA Devices recall · Reported May 29, 2024
BiPAP A40 Ventilators: BiPAP A40, Part Numbers 1111169 (US and OUS) and (OUS ONLY)1111170 1111171 1111173 1111174 1111175 1111177 1116156 1111170S BR1111169 CN1111169 IT1111169 R1111169 R1111177 R1116156 ; BiPAP A40 Pro, Part Numbers (OUS Only): ARX3100S19 AUX3100S19 BLX3100S19 BRX3100S18 CAX3100S12 CAX3100T12 DEX3100S13 EEX3100S19 ESX3100S19 FRX3100S14 GBX3100H19 GBX3100S19 IAX3100S19 INX3100H19 INX3100S19 ITX3100S21 SPX3100S19 ; BiPAP A40 EFL, Part Num
Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, re…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Philips Respironics, Inc. recalled BiPAP A40 Ventilators: BiPAP A40, Part Numbers 1111169 (US and OUS) and (OUS ONLY)1… - a critical-severity action.
BiPAP A40 Ventilators: BiPAP A40, Part Numbers 1111169 (US and OUS) and (OUS ONLY)1… was recalled by Philips Respironics, Inc. in May 29, 2024. Reason: Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This …. Check the official notice for the remedy. Verify recall #Z-1813-2024 with the FDA Devices before acting.
The recall
Philips Respironics, Inc. issued this critical-severity FDA Devices recall-Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This ….
- Critical
- severity level
- Class I
- classification
- May 29, 2024
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1813-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1813-2024) was formally reported on May 29, 2024, with the manufacturer initiating the action on March 26, 2024. It is classified under Critical severity (Class I), with a current status of Ongoing. Philips Respironics, Inc. is listed as the recalling firm, operating out of Murrysville, PA. Federal records list the affected scope as 6 US, 60,417 OUS.
The documented reason for this recall is: 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 pote… Distribution data in the federal record shows the product reached: Worldwide distribution. US Nationwide including PR and GU; Austria, Belgium, Cyprus, Czech Republic, Denmark, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Romania, Serbia, Slovakia, Spain, and Turkey.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
6 US, 60,417 OUS
Related Recalls
6
3 from same agency
Product description
BiPAP A40 Ventilators: BiPAP A40, Part Numbers 1111169 (US and OUS) and (OUS ONLY)1111170 1111171 1111173 1111174 1111175 1111177 1116156 1111170S BR1111169 CN1111169 IT1111169 R1111169 R1111177 R1116156 ; BiPAP A40 Pro, Part Numbers (OUS Only): ARX3100S19 AUX3100S19 BLX3100S19 BRX3100S18 CAX3100S12 CAX3100T12 DEX3100S13 EEX3100S19 ESX3100S19 FRX3100S14 GBX3100H19 GBX3100S19 IAX3100S19 INX3100H19 INX3100S19 ITX3100S21 SPX3100S19 ; BiPAP A40 EFL, Part Numbers (OUS Only): AUX3000S19 DEX2900S13 DEX3000S13 EEX3000S19 ESX3000S19 FRX3000S14 GBX3000S19 INX3000H19 ITX3000S21
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-1813-2024 |
| Date reported | May 29, 2024 |
| Date initiated | March 26, 2024 |
| Recalling firm | Philips Respironics, Inc. |
| Firm location | Murrysville, PA |
| Affected scope | 6 US, 60,417 OUS |
| Distribution | Worldwide distribution. US Nationwide including PR and GU; Austria, Belgium, Cyprus, Czech Republic, Denmark, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Romania, Serbia, Slovakia, Spain, and Turkey. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1813-2024) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
BiPAP A40 Ventilators: BiPAP A40, Part Numbers 1111169 (US and OUS) and (OUS ONLY)1111170 1111171 1111173 1111174 1111175 1111177 1116156 1111170S BR1111169 CN1111169 IT1111169 R1111169 R1111177 R1116156 ; BiPAP A40 Pro, Part Numbers (OUS Only): ARX3100S19 AUX3100S19 BLX3100S19 BRX3100S18 CAX3100S12 CAX3100T12 DEX3100S13 EEX3100S19 ESX3100S19 FRX3100S14 GBX3100H19 GBX3100S19 IAX3100S19 INX3100H19 INX3100S19 ITX3100S21 SPX3100S19 ; BiPAP A40 EFL, Part Numbers (OUS Only): AUX3000S19 DEX2900S13 DEX3000S13 EEX3000S19 ESX3000S19 FRX3000S14 GBX3000S19 INX3000H19 ITX3000S21. Recalled by Philips Respironics, Inc.. Units affected: 6 US, 60,417 OUS.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 29, 2024. Severity: Critical. Recall number: Z-1813-2024.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution. US Nationwide including PR and GU; Austria, Belgium, Cyprus, Czech Republic, Denmark, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Romania, Serbia, Slovakia, Spain, and Turkey..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1813-2024) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported May 29, 2024. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.