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 to help the user place the needles in a grid pattern. The letters and numbers can also correspond with computerized grids to aid in placement.
Reported: February 6, 2019 Initiated: January 9, 2018 #Z-0777-2019
Product Description
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 to help the user place the needles in a grid pattern. The letters and numbers can also correspond with computerized grids to aid in placement.
Reason for Recall
Product is labeled with "CE", but is not yet approved in the European Union.
Details
- Recalling Firm
- Riverpoint Medical, LLC
- Units Affected
- 443 devices
- Distribution
- US Nationwide Distribution in the states of IL, WA, and FL
- Location
- Portland, OR
Frequently Asked Questions
What product was 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 Riverpoint Brachytherapy Grid is placed against the skin of the patient to help the user place the needles in a grid pattern. The letters and numbers can also correspond with computerized grids to aid in placement.. Recalled by Riverpoint Medical, LLC. Units affected: 443 devices.
Why was this product recalled? ▼
Product is labeled with "CE", but is not yet approved in the European Union.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 6, 2019. Severity: Low. Recall number: Z-0777-2019.
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