FDA Device recall Z-0883-2023
Philips Trilogy 200 Ventilator, Model Numbers 1040005, U1040005, 1040005B, U1040005B, CA1032800B, CA1032800, KO1032800, 1032800, R1032804TP…
- FDA Device
- Class I
- ongoing
- Published 2023-01-18
On 2023-01-18 the FDA classified a Class I recall of Philips Trilogy 200 Ventilator, Model Numbers 1040005, U1040005, 1040005B, U1040005B, CA1032800B, CA1032800, KO1032800, 1032800, R1032804TP… by Philips Respironics, citing the replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 devices may separate from the plastic backing to which it is attached. If this were t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0883-2023 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2022-12-07 |
| Published | 2023-01-18 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Philips Respironics |
| Distribution | US |
Product
Philips Trilogy 200 Ventilator, Model Numbers 1040005, U1040005, 1040005B, U1040005B, CA1032800B, CA1032800, KO1032800, 1032800, R1032804TP, R1032804B, R1032804TPV, 1032804B
Reason
The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 devices may separate from the plastic backing to which it is attached. If this were to happen, the foam could potentially block air inlet, which could result in a reduction in delivered therapy volume or pressure and could cause the device to alarm.
Identifiers
| code_info | UDI: 00606959429154 00606959429208 00606959429147 00606959429185 00606959429710 00606959429611 00606959429475 006069594…UDI: 00606959429154 00606959429208 00606959429147 00606959429185 00606959429710 00606959429611 00606959429475 00606959429260 00606959033986 00606959033993 00606959429444; Serial Numbers: TV212103056 TV213062024 TV214101606 TV210092113 TV211113009 TV212022810 TV212062641 TV214031911 TV214040418 TV214040414 TV21404041D TV214041501 TV21404041C TV214061728 TV21406171F TV21412160E TV215030665 TV215100123 TV21706280E TV217092201 TV217122107 TV217122113 TV219090909 TV21909091B TV210081103 TV210082301 TV210092106 TV210102509 TV211051303 TV211080213 TV211092124 TV212051425 TV212062657 TV213042329 TV213050906 TV21402100B TV21403186A TV214040816 TV214060402 TV214100114 TV214100115 TV214102009 TV214102008 TV21507270A TV215100201 TV21608016D TV21608037C TV21608037B TV217120409 TV219090913 TV212062268 TV213121266 TV220111614 TV220112315 TV212062243 TV214081917 TV210072214 TV210072245 TV211060304 TV211060124 TV211060320 TV211060309 TV211092126 TV212020645 TV213012231 TV213042341 TV213092015 TV2131023 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0883-2023%22
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