Devices

Device Recall Regulation Number 892.5700

Model / Serial
All lots of the components are recalled. Components are used as adapters for the Varian Afterloaders with the following serial numbers: H600097 H600254 H600255 H600268 H600274 H600341 H600345 H600352 H600377 H600381 H600416 H600435 H600437 H600462 H600513 H600524 H600538 H600546 H600548 H600583
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - USA (nationwide) Including the states of CA, FL, IN, KY, MI, MN, MO, OH, TX, VA and the countries of Canada, Japan and Sweden.
Product Description
Nucletron Adapter and Transfer Guide Tube Set, part number AL 13005001, set of 3 adapters, components used with the VariSource" IX HDR Afterloader. || Product Usage: The adapter is part of the VariSource Afterloader System, a computer controlled remote HDR Afterloader used to place a high activity radioactive source within a needle(s) or applicator(s) which have previously been placed for a specific clinical purpose in a patient.
Manufacturer
Varian Medical Systems, Inc.
2 Events
- Recall of Device Recall Regulation Number 892.5700
- Recall of Device Recall Regulation Number 892.5700

Manufacturer

Varian Medical Systems, Inc.

Manufacturer Address
Varian Medical Systems, Inc., 700 Harris St Ste 109, Charlottesville VA 22903-4584
Manufacturer Parent Company (2017)
Varian Medical Systems Inc
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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