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Terminated

STERIS Harmony LL 500/700 Surgical Light, Vertical Spring-Loaded Arm. Intended for local illumination of the operating and examination area of the patient in treatment rooms.

FDA Recall Z-0414-2010 · Posted 2009-11-23

Recalling FirmSteris Corp
Recall StatusTerminated
Product CodeFTD
Date Initiated2009-09-11
Date Terminated2012-03-01
Product Quantity388 units

Reason for Recall

Drger Medical AG & Co., KGaA informed STERIS Corporation that they received (4) reported international cases where a welded seam at the joint of the spring-loaded arm of the Drger SOLA 500/700 surgical light broke as a result of a crack that had slowly developed over time. The STERIS Harmony LL 500/700 surgical light is a Private Label version of the Drger SOLA 500/700 surgical light.

Firm Action

The firm sent Urgent Product Correction letters, dated Sept. 11, 2009, to their customers. The letter identified the problem and stated that Drager had supplied STERIS the replacement spring arms and that a STERIS Service Technician would perform the replacement. The letter also stated that the correction would be performed at no charge to the customers. According to the letter, customers would be contacted by their STERIS Service Representative to arrange a convenient time for replacement of potentially affected spring arms. In the meantime, the letter states that customers should use their surgical lights in accordance with the guidelines presented in the Operator's Manual. Questions or concerns regarding the letter should be directed to Barbara Rich at 440-392-7318 or your local STERIS account manager.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution -- USA, including the states of AL, AR, CA, CO, CT, FL, GA, HI, IL, IN, KS, LA, MA, MN, MO, MS, NC, NH, NJ, NV, NY, OH, PA, RI, SC, TN, TX, UT, VA, WA, WI & WY and the country of Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

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

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