Aeris EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)
Reported: April 24, 2024 Initiated: March 19, 2024 #Z-1499-2024
Product Description
Aeris EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)
Reason for Recall
Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
Details
- Recalling Firm
- Philips Respironics, Inc.
- Units Affected
- 775 units
- Distribution
- Domestic: Nationwide Distribution; Foreign: AE, AR, AT, AU, BD, BE, BG, BO, BR, BS, CA, CH, CL, CN, CO, CZ, DE, DK, DZ, EC, EE, EG, ES, FI, FR, GB, GE, GF, GI, GR, GT, HK, HR, HU, ID, IE, IL, IN, IT, JE, JO, JP, KE, KR, KW, LB, LT, MA, ME, MK, MM, MQ, MT, MX, MY, NG, NL, NO, NP, NZ, OM, PA, PE, PF, PH, PK, PL, PR, PT, PY, QA, RE, RO, RS, RU, SA, SE, SG, SI, SK, TH, TN, TR, TW, UA, US, UY, VN, YT, ZA, ZW.
- Location
- Murrysville, PA
Frequently Asked Questions
What product was recalled? ▼
Aeris EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US). Recalled by Philips Respironics, Inc.. Units affected: 775 units.
Why was this product recalled? ▼
Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 24, 2024. Severity: Critical. Recall number: Z-1499-2024.
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