Harmony Insight Diagnostic Monitor Support System — Class II medical device recall Z-0746-2017
Terminated recall by Steris Corporation, reported 2016-12-21, distributed nationwide. The Drager Pendula spring arm device has a set of screws located on the spring arm that were not properly secu
| Recall number | Z-0746-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Steris Corporation, Mentor, OH, United States |
| Recall initiated | 2016-10-05 |
| Classified | 2016-12-12 |
| Reported by FDA | 2016-12-21 |
| Terminated | 2017-04-14 |
| Distributed | Nationwide (US) |
| Quantity | 63 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0746-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.