Brand Name: Fletcher CT/MR Shielded Applicator Set Product Name: Intracavitary Remote Afterloading Applicator Product Description: The Fletcher CT/MR Shielded Applicator Set is intended for gynecological brachytherapy treatment of the cervix and endometrium.
USBrand Name: Fletcher CT/MR Shielded Applicator Set Product Name: Intracavitary Remote Afterloading Applicator Product Description: The Fletcher CT/MR Shielded Applicator Set is intended for gynecological brachytherapy treatment of the cervix and endometrium.
Recalling Firm: Elekta, Inc.
Reason for Recall / Hazard
Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.
Product Description & Identification
Brand Name: Fletcher CT/MR Shielded Applicator Set Product Name: Intracavitary Remote Afterloading Applicator Product Description: The Fletcher CT/MR Shielded Applicator Set is intended for gynecological brachytherapy treatment of the cervix and endometrium.
Affected Products
Brand Name: Fletcher CT/MR Shielded Applicator Set Product Name: Intracavitary Remote Afterloading Applicator Product Description: The Fletcher CT/MR Shielded Applicator Set is intended for gynecological brachytherapy treatment of the cervix and endometrium.
Additional Source Details
| Field | Value |
|---|---|
| City | Atlanta |
| State | GA |
| Event id | 98704 |
| Address 1 | 400 Perimeter Center Ter NE Ste 50 |
| Address 2 | N/A |
| Code info | Lot Code: 08717213024205 |
| Postal code | 30346-1227 |
| Report date | 20260715 |
| Product type | Devices |
| Product quantity | 1 |
| Reason for recall | Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260403 |
| Initial firm notification | Letter |
| Center classification date | 20260709 |
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Overview
- Recalling FirmElekta, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - U.S. Nationwide distribution including in the states of AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TX, UT, VA, WI, and WV. The countries of Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Botswana, Brazil, Burkina Faso, Cambodia, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iran (Islam Republic of), Iraq, Ireland, Italy, Japan, Kazakhstan, Kenya, Korea (Republic of), Kosovo, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Rwanda, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Swaziland, Sweden, Switzerland, Taiwan, Thailand, Togo, Turkey, Ukraine, United Arab Emirates, United Kingdom, Venezuela, Viet Nam, and Zambia.
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🚨 SAFETY ALERT: Elekta, Inc. - Brand Name: Fletcher CT/MR Shielded Applicator Set Product Name: Intracavitary Remote Afterloading Applicator Product Description: The Fletcher CT/MR Shielded Applicator Set is intended for gynecological brachytherapy treatment of the cervix and endometrium. Check if your household is affected: https://therecallfile.com/recalls/brand-name-fletcher-ct-mr-shielded-applicator-set-product-name-intraca/FDA-Z-2710-2026
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