Recall Z-0414-2010 ยท FTD Lamp, Surgical
Steris Corp
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.
| Date | Nov 23, 2009 (initiated Sep 11, 2009) |
| Status | Terminated |
| Reason | 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 | 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 the |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010724 | SOLA 700,SOLA 500, SOLA 300 Drager Medizintechnik GmbH, Jun 7, 2001 |