Trilogy Evo and Trilogy Evo O2 Material Numbers BL2110X15B BR2110X18B CA2110X12B DE2100X13B DE2110X13B DS2100X11B DS2110
FDA device recall Z-0638-2024 · posted 2024-01-04 · Open, Classified
Recall details
- Recalling firm
- Philips Respironics, Inc.
- 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 patients less than 10 kg. Potential harms if devices are used on contraindicated patients include barotrauma, hypoventilation/hypercapnia, and rebreathing of excessive CO2.
- Action taken
- On November 27, 2023, the firm sent "URGENT Medical Device Correction" letters to dated November 20, 2023, affected customers along with an attached manual addendum for insertion into current manuals. Customers were instructed to keep a copy of the letter and attached addendum with their Trilogy Evo or Trilogy Evo O2 Ventilator IFUs. Distributors were instructed to notify any customers to whom they have distributed affected devices. If you need any further information or support concerning this issue, please contact your local Philips representative: Call 1-(877)-387-3311 or email at patientsupport@philips.com
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- CBK
- Quantity affected
- 100,126 (54,691 US; 45,435 OUS) in total
- Distribution
- 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,
- Date initiated
- 2023-11-27
- Date posted
- 2024-01-04
- Location
- Murrysville, PA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Trilogy Evo (K181166) | Respironics, Inc. | 2019-07-18 |