Beekley recalls TomoSPOT mole marking devices with specific model and lot numbers due to potential imaging artifacts on mammograms that could mimic calcifications.
There is a potential for imaging artifact to mimic calcifications on patient's mammograms
Beekley is recalling several models of TomoSPOT mole marking devices because they might create false calcification images on mammograms. This could lead to unnecessary biopsies or missed cancers if not addressed.
The device can create imaging artifacts that look like calcifications on mammograms. These false positives might cause unnecessary biopsies or delay in detecting actual cancers.
People who use TomoSPOT devices for mole marking during mammograms, particularly those with the listed model numbers and lot ranges. Those with a history of breast cancer or high-risk conditions may be most affected.
Check if your TomoSPOT device has model numbers 782, 782S, 783, 783S, 784, 784S, 785, or 785S. Look for the specific lot numbers listed in the recall notice for each model.
Identify your TomoSPOT device model number (782, 782S, 783, 783S, 784, 784S, 785, or 785S) and lot number from the recall list.
Reach out to Beekley Corporation for assistance with the recall process or to confirm if your device is affected.
The recall does not require immediate stop use; the hazard is low risk and the remedy is to check model and lot numbers.
Contact Beekley Corporation to confirm your device is affected and follow their instructions for the recall process.
Check the model number and lot number against the specific lists provided in the recall notice for each device model.
We’ve drafted a message you can send Beekley to request your refund or repair — edit it as you like.
Subject: Recall Z-2832-2018 — Beekley Beekley Hello, I own a Beekley that is covered by recall Z-2832-2018 from Beekley. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
