# FDA recall Z-1813-2024

> **Philips Respironics, Inc.** · Class I · device recall initiated 2024-03-26.

## Product

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.

## 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.

## Key facts

- **Recall number:** Z-1813-2024
- **Recalling firm:** Philips Respironics, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-03-26
- **Report date:** 2024-05-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Murrysville, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1813-2024

## Citation

> AI Analytics. FDA recall Z-1813-2024. Retrieved 2026-07-08 from https://api.ai-analytics.org/recall/Z-1813-2024. Source: US FDA. Licensed CC0.

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