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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 75385

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 05, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Steris Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-0746-2017
Recall number
Z-0746-2017
Initiated
October 05, 2016
Classification
Class II
Status
Terminated
Recalling firm
Steris Corporation
Quantity
63

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

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.

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

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.