510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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Z-0414-2010

STERIS Harmony LL 500/700 Surgical Light, Vertical Spring-Loaded Arm. Intended for local illumination of the...

STERIS Corporation / initiated 2009-09-11 / Terminated / root cause: design
FDA source (opens on fda.gov)

Steris Corp began a recall of 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... on . The reason FDA records is "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-0414-2010
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
STERIS Corporation
Product
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.
Product code
FTD Lamp, Surgical
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.
Root cause tag
design
FDA root cause
Device Design
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.
Quantity in commerce
388 units
Distribution
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.
Product codes and lots
Part Number: YG18568; Serial Numbers: Year 2002 - 0111 072 XXXXX to 0111 122 XXXXX; Year 2003-0111 013 XXXXX to 0111 123 XXXXX; Year 2004-0111 014 XXXXX to 0111 124 XXXXX; Year 2005-0111 015 XXXXX to 0111 125 XXXXX; and Year 2006-0111 016 XXXXX to 0111 066 XXXXX - (XXXXX means every 5-digit serial number).