Medi-Physics, Inc., Dba GE Healthcare
Country not established
- Devices
- 1
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Medi-Physics, Inc., Dba GE Healthcare makes
Medi-Physics, Inc. (DBA GE Healthcare) manufactures brachytherapy source devices, including the model 9011, designed for internal radiation therapy applications in oncology.
The company’s brachytherapy sources are classified as Class II devices under FDA regulations and are supported by 510(k) clearance records. The manufacturer operates from the United States.
Catalogue
Brachytherapy Source Device, Model 9011 Ref K081066
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Medi-Physics, Inc., Dba GE Healthcare, initiated on 2011-09-20. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2011
- 20 Sep 2011 Z-0266-2012 Unclassified (pre-2012) Terminated There is a potential brachytherapy over or under dose with the RAPID Strand Rx kit that may impact patient therapy.
Full distribution text
- 20 Sep 2011 Z-0266-2012 Unclassified (pre-2012) Terminated There is a potential brachytherapy over or under dose with the RAPID Strand Rx kit that may impact patient therapy.
Frequently asked questions
How many devices does Medi-Physics, Inc., Dba GE Healthcare have in the registry?
The registry currently lists 1 device for Medi-Physics, Inc., Dba GE Healthcare. Devices recorded under merged duplicate company entries are counted once.
Which registries list Medi-Physics, Inc., Dba GE Healthcare's devices?
Among its 1 most recently registered device, Medi-Physics, Inc., Dba GE Healthcare has devices listed in FDA 510(k) (1 device).
What risk classes do Medi-Physics, Inc., Dba GE Healthcare's devices fall under?
Among its 1 most recently registered device, the classes recorded for Medi-Physics, Inc., Dba GE Healthcare's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Medi-Physics, Inc., Dba GE Healthcare?
FDA recall records list 1 recall initiated by Medi-Physics, Inc., Dba GE Healthcare, the most recent initiated on 20 Sep 2011. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Medi-Physics, Inc., Dba GE Healthcare in the registry?
The most recently registered devices listed for Medi-Physics, Inc., Dba GE Healthcare include BRACHYTHERAPY SOURCE DEVICE, MODEL 9011.