Device product
Beekley Spots Light Image O-Spots for Mammography Catalog Number: 252 Product Usage: To identify raised moles in Mammography
Z-1787-2014
Product summary
- Event
- Event 65483
- Status
- Terminated
- Classification
- Class III
- Quantity
- 81 boxes
- Official record key
device-enforcement:Z-1787-2014
Official wording
Reason: Light Image O-Spots Dispenser mislabeled as Soft n' Stretchy Light Image S-Spots
Code information: Lot Number: 252.04261301
Distribution pattern: Worldwide Distribution - USA in the states of CA, FL, MA, NC, NY, and PA.
Derived failure modes
-
Labeling or packaging
mislabeled