Elekta Geneva Brachytherapy Applicator Intrauterine Tube Detachment Risk
Elekta is recalling the Geneva Brachytherapy Applicator due to a safety concern that the tip of the intrauterine tube may detach and remain inside a patient during cancer treatment.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II medical device recall involving a structural/functional defect (tube tip detachment) that could result in a retained foreign body inside a patient during cancer treatment, posing significant risk of harm. Class II recalls with potential for serious injury consequences are classified as Severe per the rubric.
Plain-English summary
Elekta, Inc. is recalling the Geneva Brachytherapy Applicator, a medical device used for intracavitary brachytherapy to treat cancer of the cervix and endometrium. The device may have optional needles for interstitial therapy. The recall is due to a safety concern regarding potential detachment of the tip of the intrauterine tube (IU tube), which may remain within a patient.
Approximately 1,317 units have been distributed worldwide, including throughout the United States and internationally. The affected lot codes are: 08717213056039, 08717213056053, 08717213056077, 08717213056091, 08717213056398, 08717213056411, 08717213056435, 08717213056459, 08717213056473, 08717213056497, 08717213056510, 08717213056534, 08717213056558, 08717213056572, 08717213056596, 08717213056619, 08717213056633, and 08717213056657.
Healthcare providers and patients who have received or are scheduled to receive treatment with the Geneva Brachytherapy Applicator should contact Elekta, Inc. for further information and guidance.
The recalled product
- Product
- Brand Name: Geneva Product Name: Brachytherapy Applicator Product Description: The device is intended for intracavitary brachytherapy for cancer treatment of the cervix and the endometrium. Optional needles can be placed for interstitial therapy.
- Manufacturer
- Elekta, Inc.
- Hazard
- device-detachment
- retained-foreign-body
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (18)
- Lot Code: 08717213056039
- 08717213056053
- 08717213056077
- 08717213056091
- 08717213056398
- 08717213056411
- 08717213056435
- 08717213056459
- 08717213056473
- 08717213056497
- 08717213056510
- 08717213056534
- 08717213056558
- 08717213056572
- 08717213056596
- 08717213056619
- 08717213056633
- 08717213056657
Distribution
Distributed nationwide across the United States.
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