Philips Respironics, Inc. Recall 89276
Description: Trilogy Evo Repair Kit, RP-Trilogy Evo Muffler Assembly, Material Number 1135257 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.
Philips Respironics, Inc. Recall 89276 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0494-2022 |
| Event ID | 89276 |
| Event Description | Trilogy Evo Repair Kit, RP-Trilogy Evo Muffler Assembly, Material Number 1135257 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. |
| Product Type | Devices |
| 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. |
| Quantity | 205 kits |
| Recall Reason | 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. |
| Device Classification | 20220202 |
| Device Code Info | Lot Numbers 210414 - 210524 |
| Center Classification Date | 20220121 |
| Recall Initiation Date | 20211222 |
| Recalling Firm | Philips Respironics, Inc. |
| Initial Notification | Letter |
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