Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0001-2022Class II

RAPTAR Laser Range Finders

Potomac River Group, Corp. / initiated 2021-04-21 / Open, Classified

Potomac River Group, Corp. began a recall of RAPTAR Laser Range Finders on . FDA classified it as Class II and gives the reason as "RAPTAR units are capable of being field modified to enable the use of the higher power visible and IR laser pointers and the IR Illuminator". As of , the recall status on record is Open, Classified.

Recall record

Recall number
Z-0001-2022
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Potomac River Group, Corp.
Product
RAPTAR Laser Range Finders
Product code
REP Surveying Laser Product
Reason for recall
RAPTAR units are capable of being field modified to enable the use of the higher power visible and IR laser pointers and the IR Illuminator.
FDA root cause
Radiation Control for Health and Safety Act
Action
Potomac River Group (PRG) sent communications to the purchasers of the affected units that were locked in the eye safe mode and distributed without the keys. PRG expects to offer all affected purchasers at least a refund option. PRG s ability to offer a repair option is contingent upon assistance from Wilcox, which is the only entity PRG is aware of that has the ability to render the units compliant with FDA specifications.
Quantity in commerce
62 units
Distribution
US Nationwide
Product codes and lots
RAPTAR G02 (Wilcox Part #57200G02)

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0001-2022
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0001-2022Class IIOngoingVoluntary: Firm initiated