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Terminated

Harmony LA/LED Monitor Arm Adapter. Model Number: LB61 The Harmony LA/LED Monitor Arm Adapter is an accessory to the Harmony LA and LED Surgical Lighting System and is attached to the end of the monitor suspension arm to allow Customers to attach other medical devices, such as non-STERIS monitors, camera or other compatible items in place of the STERIS monitor. The Harmony Surgical Lighting and Media System is a family of variable pattern, variable intensity surgical lights designed to provide visible immunization of the surgical field or the patient and to provide audio-visual procedural support for the O.R. staff. The device is intended to be used by surgeons and other medical care practitioners in a surgical setting

FDA Recall Z-1886-2011 · Posted 2011-04-05

Recalling FirmSteris Corporation
Recall StatusTerminated
Product CodeFSY
Date Initiated2011-02-18
Date Terminated2013-03-13
Product Quantity14 Units

Reason for Recall

The arm adapter does not contain labelling specifying the applicable weight and moment limitations of the arm adapter

Firm Action

Steris Corporation sent an Urgent Field Correction Notice letter dated February 18, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. A Steris representative would contact customers to arrange for replacement of the product. For questions regarding the firms visit to their facility, customers were instructed to contact Steris Field Service Dispatch at 1-800-333-8828. For any questions regarding this matter call 440-392-7705.

Root Cause

Other

Distribution Pattern

Worldwide Distribution - USA including CO, IL, IN, MO, NC, NV, NY and OH and the countrries of Canada, China, and Australia.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K072072HARMONY LED-1 SURGICAL LIGHTING SYSTEMSTERIS Corporation · 2007-10-05K013242AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEMSTERIS Corporation · 2001-12-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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