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Recall Observatory FDA recall evidence

Device product

Mammary Nodules Localization

Z-2491-2021

August 05, 2021

Class II

Product summary

Firm
M.D.L. S.r.l.
Event
Event 88430
Status
Terminated
Classification
Class II
Quantity
320 units
Official record key
device-enforcement:Z-2491-2021

Official wording

Reason: Sterility assurance may be compromised.

Code information: Model Number PN2010, Lots: 3620D Model Number PN2012, Lots: 1317 Model Number PN2015, Lots: 3620D Model Number PNA2005, Lots: 5216C Model Number PNA2010, Lots: 3620D Model Number PNA2015, Lots: 3620D Model Number PNAX2005, Lots: 5216C Model Number PNS2010, Lots: 3620D Model Number PNS2015, Lots: 3620D Model Number PNX2010, Lots: 0817A Model Number PR2005, Lots: 5216C, 4920B Model Number PR2007, Lots: 5216C Model Number PR2010, Lots: 3620D Model Number PR2015, Lots: 3620D

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Sterility assurance may be compromised.