International safety notice
A customer reports a ``continuous negative pressure detection'' or ``not calibrated'' alarm after ``power ON'' or ``power OFF/ON cycle''. We have received a report that a problem has occurred. The overseas manufacturer has notified us that it has been decided to recall the board as it has become clear that a similar phenomenon has occurred with the board. Received. Did.
Japan / PMDA Recalls · JPN · Jul 18, 2024
Key facts
| Title | A customer reports a ``continuous negative pressure detection'' or ``not calibrated'' alarm after ``power ON'' or ``power OFF/ON cycle''. We have received a report that a problem has occurred. The overseas manufacturer has notified us that it has been decided to recall the board as it has become clear that a similar phenomenon has occurred with the board. Received. Did. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Neonatal/pediatric ventilator Sales name: Infant ventilator SLE6000 |
| Manufacturer | TKB Co., Ltd. |
| Models | 6030761700, 6010260565, 6030561355, 6010260564, 6010361048, 6010361374, 6030761687, 6010361045, 6010460733, 6010360751, 6010460334, 6030761691 and 98 more |
| Date | Jul 18, 2024 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
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