International safety notice
As a result of an investigation by an overseas manufacturer, soundproofing foam made from polyester-based polyurethane (PE-PUR) was recalled (PMDA publication number: 2-10223), corrective measures for the Trilogy series in which PE-PUR soundproofing foam was replaced with silicone soundproofing foam. We have confirmed two problems with the product. 1) Separation of the silicone acoustic foam from the plastic backing material to which it is attached. This is a possibility., and an alarm may sound. We have received reports both domestically and internationally. 2) Although limited, some pieces of PE-PUR soundproofing foam were installed inside some equipment that was returned to the site as a corrective action item. We confirmed that particles remained. <Future plans> ・Information regarding this matter will be provided to medical institutions that own the affected products. ・Our products have functions similar to those of the target Trilogy series: Trilogy Evo series (Trilogy Ev series) O) will be exchanged sequentially in advance. ・If a repair policy using improved parts is decided, repairs will be carried out at the same time.
Japan / PMDA Recalls · JPN · Feb 8, 2023
Key facts
| Title | As a result of an investigation by an overseas manufacturer, soundproofing foam made from polyester-based polyurethane (PE-PUR) was recalled (PMDA publication number: 2-10223), corrective measures for the Trilogy series in which PE-PUR soundproofing foam was replaced with silicone soundproofing foam. We have confirmed two problems with the product. 1) Separation of the silicone acoustic foam from the plastic backing material to which it is attached. This is a possibility. , and an alarm may sound. We have received reports both domestically and internationally. 2) Although limited, some pieces of PE-PUR soundproofing foam were installed inside some equipment that was returned to the site as a corrective action item. We confirmed that particles remained. <Future plans> ・Information regarding this matter will be provided to medical institutions that own the affected products. ・Our products have functions similar to those of the target Trilogy series: Trilogy Evo series (Trilogy Ev series) O) will be exchanged sequentially in advance. ・If a repair policy using improved parts is decided, repairs will be carried out at the same time. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | General name: Artificial respirator for adults Sales name: (1) Trilogy (2) Trilogy 100 plus (3) Trilogy 200 plus |
| Manufacturer | Philips Japan Co., Ltd. |
| Models | TV11705176F, TV11811120B, TV118092779, TV118092851, TV119010239, TV12002011A, TV116071836, TV119071022, TV118012342, TV21902120B, TV117051152, TV21608291B and 6687 more |
| Date | Feb 8, 2023 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1