Z-0638-2024 Class II Ongoing
FDA device recall Z-0638-2024 was initiated by Philips Respironics, Inc. on November 27, 2023 and is designated Class II. Reason for recall: The following was missing from the Contraindications Statement: The AVAPS-AE therapy mode is contraindicated for invasive use and patients less than 10 kg. The AVAPS feature is contraindicated for p… The recall status is ongoing. Affected quantity: 100,126 (54,691 US; 45,435 OUS) in total.
Recall Details
- Product Type
- Devices
- Report Date
- January 10, 2024
- Initiation Date
- November 27, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 100,126 (54,691 US; 45,435 OUS) in total
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution: US (nationwide)-AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, Including PR; and OUS (International) including countries of: AE, AR,AT, AU, BD, BE, BG, BO, BR, CA, CH, CL, CN, CO, CZ, DE, DK, DZ, ;EC EE, EG, ES, FI, FR, GB, GE, GF, GR, GT, HK, HR, HU, IE, IL, IN, IT, JO, JP, KE, KR, KW, LB, LT, MA, ME, MK, MM, MQ, MT, MX, MY, NG, NL, NO, NP, 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, YT, ZA and ZW.