Philips Respironics, Inc. Recall: Trilogy Evo, Material Numbers DS2110X11B (USA) and KR211
Philips Respironics, Inc. Recall: Trilogy Evo, Material Numbers DS2110X11B (USA) and KR211 is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Philips Respironics, Inc.; Product: Trilogy Evo, Material Numbers DS2110X11B (USA) and KR2110X15B (Korea) The Trilogy Evo ventilator provides conti
| Recalling firm | Philips Respironics, Inc. |
|---|---|
| Product | Trilogy Evo, Material Numbers DS2110X11B (USA) and KR2110X15B (Korea) The Trilogy Evo ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. |
| Reason for recall | Philips has identified a specific lot of non-conforming material manufactured by one of its suppliers. A Philips supplier incorrectly used polyester-based polyurethane (PE-PUR) sound abatement foam, a non-conforming material in the devices and repair kits. PE-PUR foam may degrade into particles which may enter the device s air pathway and be ingested or inhaled by the user. The foam degradation may be exacerbated by use of unapproved cleaning methods such as unapproved ozone cleaners, and the PE-PUR foam may off-gas certain chemicals during initial use of the device. |
| Classification | Class I (most serious — reasonable probability of serious health consequences or death) |
| Status | Ongoing |
| Distribution | Worldwide Distribution: Distributed to the following US states: AR, CO, FL, IA, IL, KY, LA, MI, MT, OH, PA, TN, TX, UT, VA, WV, and WY; and Distributed to the following foreign countries: Argentina, Brazil, Romania, and Netherlands. |
| Recall initiated | 20211222 |
| Recall number | Z-0493-2022 |
| Category | device |
| State | PA |
| Country | United States |
$29/mo
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