Skip to content
Recall Observatory FDA recall evidence

Device product

Integra¿ LED Battery Charger, Single Bay. Product Number: 90523 The LED Headlight System Battery Charger (90523) is an accessory to the LED Headlight System: 90520US - LED Headlight w/Battery & AC/DC Power Supply - US 90520EU - LED Headlight w/Battery & AC/DC Power Supply - EU 90520UK - LED Headlight w/Battery & AC/DC Power Supply - UK 90520AU - LED Headlight w/Battery & AC/DC Power Supply - AU Product Usage: The Integra LED Headlight System Is designed to provide illumination to aid visualization during minor surgical, diagnostic, or therapeutic procedures

Z-1976-2014

June 11, 2014

Class II

Product summary

Firm
Integra LifeSciences Corp.
Event
Event 68519
Status
Terminated
Classification
Class II
Quantity
1250 battery chargers
Official record key
device-enforcement:Z-1976-2014

Official wording

Reason: LED battery chargers may prematurely fail and will not charge the LED battery as intended

Code information: Lot Numbers: IE123610, IE123710, IE123810, IE123910, IE124010, IE124110, IE124210, IE124310, IE124410, IE124510, IE124610, IE124710, IE124810, IE124910, IE125010, IE125110, IE125210, IE130110, IE130210, IE130310, IE130410, IE130510, IE130610, IE130710, IE130810, IE130910, IE131010

Distribution pattern: Worldwide Distribution - US Nationwide and the countries of Canada, Australia, Arab Emirates, Denmark, Germany, Great Britain, India, Ireland, Israel, Japan, Kuwait, Lebanon, Malta., Netherlands, Panama, Poland, Saudi Arabia, Singapore, South Africa, Spain, Sweden, and Tunisia.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    LED battery chargers may prematurely fail and will not charge the LED battery as intended