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Terminated

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

FDA Recall Z-0746-2017 · Posted 2016-12-12

Recalling FirmSteris Corporation
Recall StatusTerminated
Product CodeFTD
Date Initiated2016-10-05
Date Terminated2017-04-14
Product Quantity63

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.

Firm Action

Steris sent an Urgent Voluntary Field Correction Notice to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to remind staff personnel that Harmony Insight Diagnostic Monitor Support Systems, including the affected Drager Pendula spring arms, are not designed or intended to be placed over hospital personnel or patients and should be moved with care. Customers with questions were instructed to call 440-392-7358 or Steris Customer Service at 1-800-548-4873. For questions regarding this recall call 440-392-7231.

Root Cause

Component design/selection

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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