—#126975

Product

Vertical Spring Arm for Single or Dual Monitor Mount (Harmony LL 500 and Harmony LL 700 surgical lighting systems), Steris Corporation. Model numbers YG19051 and YG19262.

FDA product code: FSY — Light, Surgical, Ceiling Mounted
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K010724
Affected lot / code info: Model #: YG19051, Serial #'s: 01108340587, 01117338881, 011106337516, 011106337525, 011106337527, 011106337534, 011106337535, 011106337538, 011106337539, 011106337541, 011106337626, 011107338878, 011107338882, 011107338883, 011108340587, 011108340600, 0111073388883 & 011108340600A. Model #: YG19262, Serial #: ART00001 - ART00010, CADS0001 - CADS0015, CBX0001 - CBX0010 & CXSG0008 - CXSG0022.

Why it was recalled

Potential for the welded seam in affected monitor spring arms to crack and/or break.

Root cause (FDA determination)

Device Design

Action the firm took

On April 11, 2014 the firm sent Urgent Voluntary Field Correction Notices to their customers.

Recalling firm

Firm: Steris Corporation
Address: 5960 Heisley Rd, Mentor, Ohio 44060-1834

Distribution

Distribution pattern: Distribution to US (states: MA, NY, OH, PA & TX) and Canada.

Timeline

Recall initiated: 2014-04-04
Posted by FDA: 2014-06-23
Terminated: 2014-10-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #126975. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.