[Recalled] CAPNOSTREAM 20P (INTL) N W/PRINTER, Part Number CS08658-01 — The date/time, nurse call and alarm settings of the bedside patient monitors ma… | FDA 2018-07-31
A safety authority has issued a recall or warning for this item. The confirmed facts from the source notice are laid out below.
Recall details
| Product | CAPNOSTREAM 20P (INTL) N W/PRINTER, Part Number CS08658-01 |
|---|---|
| Brand / manufacturer | Oridion Medical 1987 Ltd. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0041-2019 |
| Country of notice | Israel |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 31 July 2018 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
This Class II recall concerns device products distributed in Israel and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Oridion Medical 1987 Ltd.
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.