Recall Z-2832-2018— Beekley Corporation
Class II · Terminated
Class II FDA medical device recall by Beekley Corporation, initiated 2018-06-13, terminated 2018-11-13. FDA's recall record names no specific 510(k) clearance for this event. Product: TomoSPOT REF 782, 782S, 783, 783S, 784, 784S, 785 & 785S Adhere to skin for marking and identifying moles in mammography.. Reason: There is a potential for imaging artifact to mimic calcifications on patient's mammograms.
- Recalling firm
- Beekley Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-06-13
- Terminated
- 2018-11-13
- Firm location
- Bristol, CT, United States
Product description
TomoSPOT REF 782, 782S, 783, 783S, 784, 784S, 785 & 785S Adhere to skin for marking and identifying moles in mammography.
Reason for recall
There is a potential for imaging artifact to mimic calcifications on patient's mammograms
Data sourced from openFDA. This site is unofficial and independent of the FDA.