Harmony Insight Diagnostic Monitor Support System - 100 Spring Arm (EMS) The system is intended for use in surgical oper

FDA device recall Z-0746-2017 · posted 2016-12-12 · Terminated

Recall details

Recalling firm

Steris Corporation

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.

Action taken

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

Status

Terminated

Product code

FTD

Quantity affected

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.

Date initiated

2016-10-05

Date posted

2016-12-12

Date terminated

2017-04-14

Location

Mentor, OH