Beekley recalls O-SPOT REF 791 and 791S skin markers for mammograms due to potential imaging artifacts that could mimic calcifications on mammograms. Affected units have specific lot numbers.
There is a potential for imaging artifact to mimic calcifications on patient's mammograms
Beekley Corporation recalls O-SPOT REF 791 and 791S skin markers used in mammography for potential imaging artifacts that might mimic calcifications on mammograms. This could lead to incorrect diagnoses if not addressed.
The O-SPOT markers may create imaging artifacts on mammograms that resemble calcifications. This could cause doctors to misinterpret results, potentially leading to unnecessary procedures or missed issues.
Women using mammography who apply the O-SPOT markers for mole identification are likely affected. Those with the specific lot numbers listed in the recall are most at risk.
Check if your O-SPOT marker has the model number REF 791 or 791S. Look for the specific lot numbers listed in the recall: 05311802, 03051802, and other numbers provided in the record.
Identify the lot number on your O-SPOT marker to see if it matches the listed numbers in the recall.
The O-SPOT markers may create imaging artifacts on mammograms that could mimic calcifications, potentially causing misdiagnosis.
The recall does not specify a remedy, so check the lot number and contact Beekley Corporation for further instructions.
Yes, the recall lists specific lot numbers for REF 791 and 791S, including 05311802, 03051802, and others.
We’ve drafted a message you can send Beekley to request your refund or repair — edit it as you like.
Subject: Recall Z-2830-2018 — Beekley Beekley Hello, I own a Beekley that is covered by recall Z-2830-2018 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.
