Product Wiki · Recalls · U.S. FDA — Device Enforcement

IVEA Product Part Number 16100 Model 500A — recall Z-3239-2017

U.S. FDA — Device Enforcement · United States · 2017-08-24 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-3239-2017
Date of alert
2017-08-24
Country / jurisdiction
United States
Risk level
Class II
Notice type
recall
Brand
Firefly Medical, Inc.
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
United States, Australia, Belgium, Canada, China, Germany, Hong Kong, Indonesia, Israel, Netherlands, Singapore, UAE
Reported risk: The dowel pins (P/N 16082) that fit in the left and right leg pivot castings (P/Ns 16049/16056) can rotate and gradually maneuver out of the leg casting after several hundred deployment and folding cycles (designed for easy storage) of the IVEA unit.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.