Steris Harmony Equipment Management System Recalled for Drive Screw Failure Risk
Steris Corporation is recalling 127 Harmony Equipment Management Systems because a drive screw in the ceiling supply unit may break, causing the adjustable arm to drop.
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 where a mechanical failure could cause the equipment to drop, but the source text does not report any injuries or illnesses.
Plain-English summary
Steris Corporation is recalling 127 units of the Harmony Equipment Management System, Model #603X/80XX. These systems are used in hospital facilities to provide access to medical gases, electrical power, and audio/visual data services, as well as to manage surgical support equipment such as endoscopic equipment, cautery devices, and insufflators.
The recall was initiated after Dräger Medical GmbH notified STERIS of a potential break in the drive screw contained in the motorized ceiling supply unit. This component controls the motorized adjustment of the height and rotation of the supply column. If the drive screw breaks, the adjustable arm may drop down, posing a risk to the EMS system.
The affected units were distributed nationwide in the United States, including Alabama, Arkansas, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Texas, Virginia, Washington, and Wisconsin. Affected serial numbers range from 0422503114 to 0426604096. Hospital facilities should contact STERIS Corporation for further instructions on how to address this issue.
The recalled product
- Product
- Harmony Equipment Management System, Model #603X/80XX, STERIS Corporation, Mentor, OH Harmony Equipment Management Systems (EMS) are used in hospital facilities to provide ready access to medical gasses, electrical power and audio/visual data services, in addition to managing…
- Manufacturer
- Steris Corporation
- Affected units
- 127
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial numbers 0422503114 - 0426604096
Distribution
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