Recall Z-0746-2017— Steris Corporation
Class II · Terminated
Class II FDA medical device recall by Steris Corporation, initiated 2016-10-05, terminated 2017-04-14. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: 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..
- Recalling firm
- Steris Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-10-05
- Terminated
- 2017-04-14
- Firm location
- Mentor, OH, United States
Product description
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
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.