Agency classClass IOur severity:Severe FDA (Devices)·Z-0925-2021·Announced 2021-02-10

Hill-Rom Liko Multirall 200 Overhead Lifts Recalled for Detachment Risk

Hill-Rom is recalling Liko Multirall 200 overhead lifts because a strap lock may not fully engage, causing the lift to detach from the rail and potentially drop the patient.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 that can lead to the fall of a patient and the lift motor, which constitutes a significant injury risk. This aligns with the rubric for 'Severe' severity, which includes structural vehicle defects or significant injury reports, and is consistent with the FDA Class I classification provided in the metadata.

Plain-English summary

Hill-Rom, Inc. is recalling Liko Multirall 200 overhead lifts and associated components due to a safety defect. The recall affects 10,470 units, with an expanded recall adding 154 units. The affected devices are general-purpose lifts intended for use in healthcare, intensive care, and rehabilitation settings.

The recall is being issued because the Multirall Q-link strap lock has not been fully engaged in the S65 rail carriage hook by the user. This failure can lead to the Multirall lift becoming detached from the rail system, potentially resulting in the fall of both the lift motor and the patient. The affected serial numbers are those less than 6511935 (manufactured before September 24, 2019), with specific exceptions for reworked units, as well as additional serial numbers identified in the expanded recall.

The devices were distributed worldwide, including in the United States and numerous other countries. Users should stop using the affected devices immediately and contact Hill-Rom, Inc. for instructions on how to proceed with the recall and repair or replacement.

The recalled product

Product: Liko Multirall 200 overhead lift- overhead lift is a general-purpose lift with the intended use in healthcare, intensive care and rehabilitation. Affected devices: Liko Multirall 200 (product number 3130001) Universal SlingBar 450 R2R (product number 3156095) Universal…
Manufacturer: Hill-Rom, Inc.
Category: Medical Device — Patient Lifts
Hazard: fall-injury
structural-defect

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 (20)

6511701
6511704
6511706
6511713
6511707
6511709
6511719
6511708
6511689
6511702
6511703
6511691
6511694
6511714
6511690
6511383
6511358
6511375
6511386
6511380

Distribution

Distributed nationwide across the United States.

Same manufacturer · Hill-Rom, Inc.

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Same hazard · fall injury