Steris Recalls Harmony Insight Diagnostic Monitor Support Systems
Steris Corporation is recalling 63 Harmony Insight Diagnostic Monitor Support Systems because spring arm screws may not be properly secured and could become loose.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device in a surgical setting) where injury has not yet been reported, fitting the 'High' severity criteria for potential mechanical failure without confirmed adverse events.
Plain-English summary
Steris Corporation is recalling 63 units of the Harmony Insight Diagnostic Monitor Support System - 100 Spring Arm (EMS). The recall is due to a defect where a set of screws located on the spring arm were not properly secured with Loctite, which may cause the screws to become loose.
The affected devices are intended for use in surgical operating rooms or intraoperative surgical/imaging rooms where simultaneous multiple image viewing is required. The recall covers units distributed nationwide, including in Alaska, Arizona, California, Colorado, Florida, Illinois, Kentucky, Michigan, Missouri, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Utah, Washington, and West Virginia.
Healthcare facilities should stop using the affected devices and contact Steris Corporation for instructions on how to resolve the issue. The specific lot codes for the affected units are listed in the official recall documentation.
The recalled product
- 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
- Manufacturer
- Steris Corporation
- Affected units
- 63
Distribution
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