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Steris Corporation recalls Harmony Insight Diagnostic Monitor Support System - 100 Spring Arm (EMS) The system is intended for use in surgical ope
Recalled December 21, 2016 · FDA recall Z-0746-2017 · Steris
Hazard
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. · FDA Class II
Units
63
Sold at
Nationwide Distribution including AK, AZ, CA, CO, FL, IL, KY, MI, MO, NB, NJ, NY, OH, PA, RI, SD, TN, TX, UT, WA & WV.
Description
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.
Product
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
Manufacturer(s)
Steris Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →