Device recall

Z-1268-2016: Helios HL3T and HLT Track Mounted Dental Lights Product Usage: The product is…

FDA device recall · Class II · Pelton & Crane / Marus / DCI Equipment / KaVo

Key facts

Recall number (Z-number) Z-1268-2016
Recall event 73460
Product Helios HL3T and HLT Track Mounted Dental Lights Product Usage: The product is intended for use by dental professionals to illuminate the oral cavity while performing examinations and dental procedures.
Product code EAZ
Recalling firm Pelton & Crane / Marus / DCI Equipment / KaVo
Recall class Class II
Status Terminated
Termination date Jun 6, 2016
FEI number 1017522

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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