[Recalled] RP RIVERPOINT MEDICAL 18G Brachy Grid B&K(TM) style, REF RPG-18 Product Usage: The Riverpoint Brachytherapy Grid is used during Brachytherapy procedures to assist with the precise insertion of the needle or other probes. The
Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.
Recall details
| Product | RP RIVERPOINT MEDICAL 18G Brachy Grid B&K(TM) style, REF RPG-18 Product Usage: The Riverpoint Brachytherapy Grid is used during Brachytherapy procedures to assist with the precise insertion of the needle or other probes. The Riverpoint Brachytherapy Grid is placed against the skin of the patient |
|---|---|
| Brand / manufacturer | Riverpoint Medical, LLC |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0777-2019 |
| Country of notice | United States |
| Risk level | Class III |
| Hazard type | recall |
| Notice date | 09 January 2018 |
| EAN / barcode | 18061816 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Product is labeled with "CE", but is not yet approved in the European Union.
This Class III recall concerns device products distributed in United States 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 Riverpoint Medical, LLC
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.