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U.S. Department of Health and Human Services

Class 2 Device Recall Harmony Insight Diagnostic Monitor Support System

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  Class 2 Device Recall Harmony Insight Diagnostic Monitor Support System see related information
Date Initiated by Firm October 05, 2016
Date Posted December 12, 2016
Recall Status1 Terminated 3 on April 14, 2017
Recall Number Z-0746-2017
Recall Event ID 75385
Product Classification Lamp, surgical - Product Code FTD
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
Code Information 0419016160 0421416123 0420816119 0415216095 0409016039 0409016038 0404716127 0434815015 0429915001 0429915002 0418015066 0418015065 0416815002 0416015002 0416015001 0413515012 0409615011 0407615001 0407615002 0405015102 0429614003 0401515015 0431714001 0430914002 0430914001 0427614022 0428014006 0423914014 0421714007 0416814001 0415014002 0414314082 0413914001 0412714043 0411414001 0411414003 0411414002 0411114001 0401614001 0404814128 0405014014 0403814116 0402214076 0401314131 0401514013 0400614027 0434413019 0433813017 0429113164 0430113149 0427313064 0417013083 0414813001 0412113002 0412113001 0410013001 0405213038 0404413018 0404413017 0404413016 0404413016 0436112019 0436112018 0434912001
Recalling Firm/
Manufacturer		 Steris Corporation
5960 Heisley Rd
Mentor OH 44060-1834
For Additional Information Contact Ms. Kathryn A. Cadorette
440-392-7231
Manufacturer 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.
FDA Determined
Cause 2		 Component design/selection
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.
Quantity in Commerce 63
Distribution Nationwide Distribution including AK, AZ, CA, CO, FL, IL, KY, MI, MO, NB, NJ, NY, OH, PA, RI, SD, TN, TX, UT, WA & WV.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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