Steris Corporation recalls Harmony Insight Diagnostic Monitor Support System - 100 Spring Arm (EMS) The system is intended for use in surgical ope…

Recall date

October 5, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0746-2017

FDA classification

Class II

Brand / firm

Steris Corporation

Sold / distributed

Nationwide Distribution including AK, AZ, CA, CO, FL, IL, KY, MI, MO, NB, NJ, NY, OH, PA, RI, SD, TN, TX, UT, WA & WV.

Why it was recalled

The Drager Pendula spring arm device has a set of screws located on the spring arm that were not properly secured with Loctite and may become loose.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Harmony Insight Diagnostic Monitor Support System - 100 Spring Arm (EMS) The system is intended for use in surgical operating rooms (OR) or intraoperative surgical/imaging rooms where simultaneous multiple image viewing is required