Hill-Rom Recalls Liko Overhead Rail Systems Due to Corrosion
Hill-Rom is recalling Liko Overhead Rail Systems because hardware corrosion in high-humidity areas caused two rail failures.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a structural defect in a medical device where the rails fell while in use, posing a significant risk of injury to patients or staff, which aligns with the 'Severe' criteria for significant injury reports or structural defects.
Plain-English summary
Hill-Rom, Inc. is recalling 3,816 Liko Overhead Rail Systems. These ceiling-mounted rail systems are used with Liko stationary lifts, including Likorall, Multirall, and Masterlift systems, to allow overhead lifts to be mounted to ceilings for versatility in lifting situations.
The recall was initiated after the company received two reports from facilities alleging that the overhead rails fell down while in use in high-humidity areas, specifically swimming pools. Analysis of these incidents suggests that the hardware components used to secure the rail to the ceiling had corroded and may be unsuitable for environments with a corrosive atmosphere.
The affected products were distributed nationwide in the United States and in several Canadian provinces. The components are not serialized and have been distributed since the early 1980s. Users should stop using the equipment and contact Hill-Rom for instructions on remediation.
The recalled product
- Product
- Liko Overhead Rail System, Ceiling Mounted Rail Systems for all Liko Stationary Lifts including Likorall, Multirall and Masterlift Systems Product Usage - The Overhead Rail System allows overhead lifts to be mounted to the ceiling allowing versatility for use in lifting…
- Manufacturer
- Hill-Rom, Inc.
- Category
- Medical Device — Patient Lifts
- Affected units
- 3,816
Distribution
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